Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- CDNUrease, Photometric, Urea Nitrogen2Product Code
- CDOAcid, Uric, Uricase (U.V.)1Product Code
- CDPRadioimmunoassay, Total Triiodothyronine2Product Code
- CDEChromatographic Separation/Zimmerman, 17-Ketosteroids1Product Code
- CHARadioimmunoassay, Corticosterone1Product Code
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin1Product Code
- CDGChromatography Separation/Zimmerman 17-Ketogenic Steroids1Product Code
- CDHAcid, Uric, Phosphotungstate Reduction1Product Code
- CDKAcid, Vanilmandelic, Electrophoretic Separation1Product Code
- CDLBerthelot Indophenol, Urea Nitrogen2Product Code
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)1Product Code
- CCYZimmerman (Spectrophotometric), 17-Ketosteroids1Product Code
- CCZZimmerman/Norymberski, 17-Ketogenic Steroids1Product Code
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin1Product Code
- CDBPorter Silber Hydrazone, 17-Hydroxycorticosteroids1Product Code
- CDCL-Leucyl B-Naphthylamide, Leucine Aminopeptidase1Product Code
- CDDRadioassay, Vitamin B122Product Code
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen2Product Code
- CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine1Product Code
- CDSElectrode, Ion Specific, Urea Nitrogen2Product Code
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1Product Code
- CDWDiacetyl-Monoxime, Urea Nitrogen2Product Code
- CDXRadioimmunoassay, Total Thyroxine2Product Code
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone1Product Code
- CEATlc Chromatographic Separation Triglycerides1Product Code
- CECRadioimmunoassay, Free Thyroxine2Product Code
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase1Product Code
- CEERadioimmunoassay, Thyroxine-Binding Globulin2Product Code
- CEFElectrophoretic, Protein Fractionation1Product Code
- CEIUranyl Acetate/Zinc Acetate, Sodium2Product Code
- CEJTetraphenyl Borate, Colorimetry, Potassium2Product Code
- CEKBiuret (Colorimetric), Total Protein2Product Code
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids1Product Code
- CEMElectrode, Ion Specific, Potassium2Product Code
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)1Product Code
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1Product Code
- CEPRadioimmunoassay, Luteinizing Hormone1Product Code
- CEQMolybdenum Blue Method, Phospholipids1Product Code
- CER2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase2Product Code
- CESChromogenesis, Phenylketones (Urinary, Non-Quant.)1Product Code
- CETOlive Oil Emulsion (Turbidimetric), Lipase1Product Code
- CEWRadioimmunoassay, Parathyroid Hormone2Product Code
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes2Product Code
- CFAElectrode, Ion Specific, Magnesium1Product Code
- CFBChromatographic Derivative, Total Lipids1Product Code
- CFDSulfophosphovanillin, Colorimetry, Total Lipids1Product Code
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes2Product Code
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase1Product Code
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase2Product Code
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase2Product Code
- CFLRadioimmunoassay, Human Growth Hormone1Product Code
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)1Product Code
- CFOTitrimetric, Magnesium1Product Code
- CFPRadioimmunoassay, Immunoreactive Insulin1Product Code
- CFRHexokinase, Glucose2Product Code
- CFTRadioimmunoassay, Prolactin (Lactogen)1Product Code
- CFWCopper Reduction, Glucose2Product Code
- CGAGlucose Oxidase, Glucose2Product Code
- CGCRadioimmunoassay, Gastrin1Product Code
- CGDFerricyanide, Glucose2Product Code
- CGEOrthotoluidine, Glucose2Product Code
- CGFRadioimmunoassay, Estrone1Product Code
- CGHElectrophoretic, Globulin1Product Code
- CGIRadioimmunoassay, Estriol1Product Code
- CGJRadioimmunoassay, Follicle-Stimulating Hormone1Product Code
- CGLElectrode, Ion Based, Enzymatic, Creatinine2Product Code
- CGNAcid, Folic, Radioimmunoassay2Product Code
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol1Product Code
- CGRRadioimmunoassay, Cortisol2Product Code
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2Product Code
- CGTRadioimmunoassay, Cyclic Gmp2Product Code
- CGXAlkaline Picrate, Colorimetry, Creatinine2Product Code
- CGZElectrode, Ion-Specific, Chloride2Product Code
- CHCTitrimetric Permanganate And Bromophenol Blue, Calcium2Product Code
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol1Product Code
- CHERadioimmunoassay, Corticoids1Product Code
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride2Product Code
- CHHEnzymatic Esterase--Oxidase, Cholesterol1Product Code
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- CIJSaccharogenic, Amylase2Product Code
- CIKRadial Diffusion, Amylase2Product Code
- CILCresol Red Colorimetry, Carbon-Dioxide2Product Code
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes2Product Code
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CIQDiazo, Ast/Sgot2Product Code
- CISHydrazone Colorimetry, Ast/Sgot2Product Code
- CITNadh Oxidation/Nad Reduction, Ast/Sgot2Product Code
- CIWStarch-Dye Bound Polymer, Amylase2Product Code
- CIXBromcresol Green Dye-Binding, Albumin2Product Code
- CIYRadioimmunoassay, Androsterone1Product Code
- CIZRadioimmunoassay, Androstenedione1Product Code
- CJAAmyloclastic, Amylase2Product Code
- CJBChromatographic Separation/Radioimmunoassay, Aldosterone2Product Code
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase1Product Code
- CJDNitrosalicylate Reduction, Amylase2Product Code
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJFTetrabromophenolphthalein, Albumin2Product Code
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin2Product Code
- CJHThymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJIDisodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJJDiazo, Alt/Sgpt1Product Code
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJMRadioimmunoassay, Aldosterone2Product Code
- CJNAcid Phosphatase, Nitrophenylphosphate2Product Code
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJQRadial Immunodiffusion, Albumin2Product Code
- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
- CJTHydrazone Colorimetry, Aldolase1Product Code
- CJWBromcresol Purple Dye-Binding, Albumin2Product Code
- CJXAcid Phosphatase, Disodium Phenylphosphate2Product Code
- CJYAzo Dye, Calcium2Product Code
- CJZAcid, Hydroxyazobenzene-Benzoic, Albumin2Product Code
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt1Product Code
- CKBAcid Phosphatase, Naphthyl Phosphate2Product Code
- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate2Product Code
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CKGRadioimmunoassay, Acth2Product Code
- CKHAcid Phosphatase, Beta Glycerophosphate2Product Code
- DHASystem, Test, Human Chorionic Gonadotropin2Product Code
- GIMTubes, Vacuum Sample, With Anticoagulant2Product Code
- GJETray, Blood Collection2Product Code
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited2Product Code
- JFJCatalytic Methods, Amylase2Product Code
- JFLPh Rate Measurement, Carbon-Dioxide2Product Code
- JFMEnzymatic Method, Bilirubin2Product Code
- JFNAtomic Absorption, Calcium2Product Code
- JFOFluorometric, Calcium2Product Code
- JFPElectrode, Ion Specific, Calcium2Product Code
- JFSCoulometric, Chloride2Product Code
- JFTFluorometric, Cortisol2Product Code
- JFYEnzymatic Method, Creatinine2Product Code
- JGCTryptophan Measurement (Colorimetric), Globulin1Product Code
- JGDNephelometric Method, Globulin1Product Code
- JGETurbidimetric Method, Globulin1Product Code
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes2Product Code
- JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase1Product Code
- JGIAtomic Absorption, Magnesium1Product Code
- JGJPhotometric Method, Magnesium1Product Code
- JGKFerric Chloride, Phenylketones (Urinary, Non-Quant.)1Product Code
- JGMFlame Photometry, Potassium2Product Code
- JGPLowry (Colorimetric), Total Protein2Product Code
- JGQTurbidimetric, Total Protein2Product Code
- JGRRefractometric, Total Protein2Product Code
- JGSElectrode, Ion Specific, Sodium2Product Code
- JGTFlame Photometry, Sodium2Product Code
- JGWFluorometric Method, Triglycerides1Product Code
- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
- JGZO-Phthalaldehyde, Urea Nitrogen2Product Code
- JHAAcid, Uric, Uricase (Gasometric)1Product Code
- JHCAcid, Uric, Uricase (Oxygen Rate)1Product Code
- JHDFluorometric Method, 17-Hydroxycorticosteroids1Product Code
- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio2Product Code
- JHHElectrophoretic Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHIVisual, Pregnancy Hcg, Prescription Use2Product Code
- JHJAgglutination Method, Human Chorionic Gonadotropin2Product Code
- JHLMicrodensitometry Method, Lipoproteins1Product Code
- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
- JHOElectrophoretic Separation, Lipoproteins1Product Code
- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes2Product Code
- JHTChromatographic Separation, Cpk Isoenzymes2Product Code
- JHWU.V. Method, Cpk Isoenzymes2Product Code
- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
- JIAEnzymatic Methods, Galactose1Product Code
- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
- JIDPhotometric Method, Ammonia1Product Code
- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
- JIKDry Ash Method, Protein-Bound Iodine1Product Code
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2Product Code
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
- JKATubes, Vials, Systems, Serum Separators, Blood Collection2Product Code
- K251812Steripath® Flow™ Blood Collection System2Cleared 510(K)
- K243207BD Vacutainer® Eclipse™ Blood Collection Needle2Cleared 510(K)
- K250961Blood collection tube holders2Cleared 510(K)
- K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)2Cleared 510(K)
- K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set2Cleared 510(K)
- K243649BD Vacutainer® Multiple Sample Luer Adapter2Cleared 510(K)
- K241586PIVO™ Pro Needle-free Blood Collection Device2Cleared 510(K)
- K242320BD Vacutainer® One Use Holder2Cleared 510(K)
- K233979VACUETTE® QUICKSHIELD Complete (Plus)2Cleared 510(K)
- K232781Safety Sliding Blood Collection Set2Cleared 510(K)
- K231373BD Vacutainer® K2 EDTA Blood Collection Tubes2Cleared 510(K)
- K231282LifeOutcomes C-Quest™ Blood Culture Sampling Device2Cleared 510(K)
- K231237BD Vacutainer® Fluoride Blood Collection Tubes2Cleared 510(K)
- K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder2Cleared 510(K)
- K230855BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes2Cleared 510(K)
- K232308Monarch Blood Collection Set2Cleared 510(K)
- K230391BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube2Cleared 510(K)
- K213146Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen2Cleared 510(K)
- K220458UltraFlo-R Push Button Blood Collection Set2Cleared 510(K)
- K230865PIVO™ Pro Needle-free Blood Collection Device2Cleared 510(K)
- K213953BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes2Cleared 510(K)
- K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood2Cleared 510(K)
- K223854Unistik® ShieldLock, Unistik VacuFlip2Cleared 510(K)
- K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)2Cleared 510(K)
- K220677Kurin Blood Culture Collection Set with Kurin Lock Technology2Cleared 510(K)
- K223323Blood Collection Needle (with/without Needle Holder)2Cleared 510(K)
- K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder2Cleared 510(K)
- K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device2Cleared 510(K)
- K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)2Cleared 510(K)
- K222834Safety Push Button Blood Collection Set2Cleared 510(K)
- K222299Steripath Micro Blood Collection System2Cleared 510(K)
- K213690Eclipse Blood Collection Set2Cleared 510(K)
- K222141Safety Blood Collection Needle (Without Needle Holder)2Cleared 510(K)
- K201237Velano Vascular Blood Collection Adapter2Cleared 510(K)
- K213718SOL-GUARD Safety Pull Button Collection Set2Cleared 510(K)
- K220799K-SHIELD Zen2Cleared 510(K)
- K220900Safety Blood Collection Needles with/without Needle Holder2Cleared 510(K)
- K22025820G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)2Cleared 510(K)
- K212724BD Vacutainer UltraTouch Push Button Blood Collection Set2Cleared 510(K)
- K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single2Cleared 510(K)
- K201009CHIRAVAC Blood Collection Needles2Cleared 510(K)
- K202325EasyPoint Blood Collection Plus2Cleared 510(K)
- K202188Safety Blood Collection Sets for Single Use2Cleared 510(K)
- K202446BD Preset Syringe & BD A-Line Syringe2Cleared 510(K)
- K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter2Cleared 510(K)
- K193074Bevel Up Holder2Cleared 510(K)
- K192247Steripath Gen2 Blood Collection System2Cleared 510(K)
- K191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)2Cleared 510(K)
- K193569PIVO(TM)2Cleared 510(K)
- K181754Blood Collection Accessory (BUCA)2Cleared 510(K)
- K181743Blood Transfer Accessory (BTA)2Cleared 510(K)
- K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)2Cleared 510(K)
- K190604PIVO2Cleared 510(K)
- K182078MiniCollect K2E K2EDTA Tubes2Cleared 510(K)
- K181895Kurin PIV Blood Collection Set with High Pressure2Cleared 510(K)
- K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder2Cleared 510(K)
- K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder2Cleared 510(K)
- K163508PIVO2Cleared 510(K)
- K162233Kurin Blood Culture Collection Set2Cleared 510(K)
- K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube2Cleared 510(K)
- K153309BD Vacutainer UltraTouch Push Button Blood Collection Set2Cleared 510(K)
- K152924TIVA¿2Cleared 510(K)
- K142946TIVA2Cleared 510(K)
- K133303PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device2Cleared 510(K)
- K123987IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET2Cleared 510(K)
- K122355VANISHPOINT BLOOD COLLECTION SET2Cleared 510(K)
- K122687BLOOD CULTURE HOLDER2Cleared 510(K)
- K120490QUICK SAMPLER HOLDER2Cleared 510(K)
- K103041VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR2Cleared 510(K)
- K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBE2Cleared 510(K)
- K101502BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 3687742Cleared 510(K)
- K093972BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 3637062Cleared 510(K)
- K091292BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 3687712Cleared 510(K)
- K090737HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI2Cleared 510(K)
- K081929VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR2Cleared 510(K)
- K081229SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING2Cleared 510(K)
- K072783SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH2Cleared 510(K)
- K063852ACCESSA CHOLESTEROL PANEL2Cleared 510(K)
- K062932AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER2Cleared 510(K)
- K063357MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES2Cleared 510(K)
- K061979MODIFICATION TO MYALLERGY TEST2Cleared 510(K)
- K060364VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE2Cleared 510(K)
- K051019SAFETY NEEDLE2Cleared 510(K)
- K043143SAFEPICO2Cleared 510(K)
- K040107CYTO-CHEX BCT2Cleared 510(K)
- K041358VENOJECT LUER ADAPTER2Cleared 510(K)
- K041071BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/3683812Cleared 510(K)
- K030394FLUID SAMPLE RETRIEVAL SYSTEM2Cleared 510(K)
- K030815AKERS LABORATORIES INC. BLOOD CELL SEPARATOR2Cleared 510(K)
- K030596IMMUNICON CELLSAVE PRESERVATIVE TUBE2Cleared 510(K)
- K030076PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM2Cleared 510(K)
- K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 3673412Cleared 510(K)
- K023971VACUETTE TRACE ELEMENTS TUBES2Cleared 510(K)
- K023331BD VACUTAINER SST II PLUS TUBES2Cleared 510(K)
- K023075BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE2Cleared 510(K)
- K021698MY ALLERGY TEST2Cleared 510(K)
- K022875MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET2Cleared 510(K)
- K022426BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,365382Cleared 510(K)
- K022130BD VACUTAINER PLUS PST II TUBE2Cleared 510(K)
- K021941SAMPLOK LUER KIT2Cleared 510(K)
- K012221SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM2Cleared 510(K)
- K013971BD VACUTAINER SAFETY COAGULATION TUBE2Cleared 510(K)
- K011699VACUETTE EVACUATED BLOOD COLLECTION TUBES2Cleared 510(K)
- K002456MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 3659922Cleared 510(K)
- K002777VACUETTE WITH PPACK2Cleared 510(K)
- K993787APPRAISE-CARDIO SAMPLE COLLECTION KIT2Cleared 510(K)
- K000777SAMPLOK2Cleared 510(K)
- K991551VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE2Cleared 510(K)
- K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 365782Cleared 510(K)
- K992244GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE2Cleared 510(K)
- K991843GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE2Cleared 510(K)
- K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE2Cleared 510(K)
- K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)2Cleared 510(K)
- K983952GREINER VACUETTE BLOOD COLLECTION TUBE2Cleared 510(K)
- K983490TERUMO VENOJECT,LUER ADAPTER2Cleared 510(K)
- K983517SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K982998GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE2Cleared 510(K)
- K982999GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE2Cleared 510(K)
- K982922VACUTAINER BRAND BLOOD COLLECTION SYRINGE2Cleared 510(K)
- K981973SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K981013VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE2Cleared 510(K)
- K981035PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES2Cleared 510(K)
- K980414VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET2Cleared 510(K)
- K980098VACUTAINER BRAND PRONTO NEEDLES HOLDER2Cleared 510(K)
- K974873VACUETTE (MULTI-USE HOLDER)2Cleared 510(K)
- K974374SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV2Cleared 510(K)
- K971111TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER2Cleared 510(K)
- K971220GREINER VACUETTE BLOOD COLLECTION TUBE2Cleared 510(K)
- K971239GREINER VACUETTE BLOOD COLLECTION TUBE2Cleared 510(K)
- K971236GREINER VACUETTE BLOOD COLLECTION TUBE2Cleared 510(K)
- K964698SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT2Cleared 510(K)
- K965202VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET2Cleared 510(K)
- K962158PICO MODELS 30, 50, 702Cleared 510(K)
- K962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT2Cleared 510(K)
- K960860GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K32Cleared 510(K)
- K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR2Cleared 510(K)
- K960857GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR2Cleared 510(K)
- K960250VACUTAINER BRAND PLUS SERUM & SST TUBES2Cleared 510(K)
- K936240SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)2Cleared 510(K)
- K954592VACUTAINER BRAND PST PLASMA SEPARATION TUBE2Cleared 510(K)
- K953994SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM2Cleared 510(K)
- K953463VACUTAINER PLUS TUBES2Cleared 510(K)
- K952516PRO-VENT, LINE DRAW, PULSATOR2Cleared 510(K)
- K935564SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION2Cleared 510(K)
- K935588SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION2Cleared 510(K)
- K926253SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE2Cleared 510(K)
- K944083MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE2Cleared 510(K)
- K944618NEONATAL BLOOD COLLECTION AND SCREENING FORM2Cleared 510(K)
- K950432VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER2Cleared 510(K)
- K945454LEUR TIP CAP, VLT CAP(TM)2Cleared 510(K)
- K945245BLOOD KIT, SEXUAL ASSAULT KIT2Cleared 510(K)
- K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE2Cleared 510(K)
- K945777PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES2Cleared 510(K)
- K945353CLARIT(TM)2Cleared 510(K)
- K944566VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE2Cleared 510(K)
- K942241DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN2Cleared 510(K)
- K942240DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN2Cleared 510(K)
- K940905MICROTAINER BRAND TUBE WITH EDTA(K2)2Cleared 510(K)
- K941159DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G2Cleared 510(K)
- K922343TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT2Cleared 510(K)
- K933401THE BUCK2Cleared 510(K)
- K935081DIRECTDRAW SUPERSERUM-MINI2Cleared 510(K)
- K931368MICROTAINER BRAND TUBE WITH EDTA2Cleared 510(K)
- K922342TRI-TECH INC. CUSTOM BLOOD ALCOHOL2Cleared 510(K)
- K931924MARKSMAN ARTERIAL BLOOD GAS SYRINGE2Cleared 510(K)
- K931367VACUTAINER BRAND LUER ADAPTER2Cleared 510(K)
- K924362VACUPLUS TUBES WITH LAVANDER STOPPERS2Cleared 510(K)
- K924364VACUPLUS TUBES WITH GREY STOPPERS2Cleared 510(K)
- K924361VACUPLUS TUBES WITH GREEN STOPPERS2Cleared 510(K)
- K924363VACUPLUS(R) STAR-SEP(TM)2Cleared 510(K)
- K924365VACUPLUS TUBES WITH BRICK RED STOPPERS2Cleared 510(K)
- K923090SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD2Cleared 510(K)
- K922445VACU-PRO2Cleared 510(K)
- K921520VACUTAINER BRAND LUER ADAPTER2Cleared 510(K)
- K921806VACUTAINER(R) BRAND SST(R) AND CAT TUBES2Cleared 510(K)
- K915814SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS2Cleared 510(K)
- K913399QBC E-Z PREP2Cleared 510(K)
- K910970MARKSMAN ARTERIAL BLOOD GAS SYRINGE2Cleared 510(K)
- K914129DIFF SAFE2Cleared 510(K)
- K911809NEW-VENT2Cleared 510(K)
- K911638SYRINGE TIP CAP2Cleared 510(K)
- K910646SUPERSERUM REAGENT (SSR)2Cleared 510(K)
- K902442SUDORMED SWEAT PATCH SPECIMEN CONTAINER2Cleared 510(K)
- K900856VEN-O-VAC BLOOD COLLECTION VACUUM TUBES2Cleared 510(K)
- K901756INTERJECTOR BLOOD COLLECTION DEVICE2Cleared 510(K)
- K901449VACUTAINER PLUS WITH HEMOGARD CLOSURE2Cleared 510(K)
- K902709SECUTAINER2Cleared 510(K)
- K900726MICROTEK MEDICAL'S BLOOD COLLECTION KIT2Cleared 510(K)
- K900309VENOJECT II BLOOD COLLECTION TUBES2Cleared 510(K)
- K896206STATSPIN STATSAMPLER2Cleared 510(K)
- K892665PRO-JECT(TM) SAFETY NEEDLE HOLDER2Cleared 510(K)
- K884970PINSET2Cleared 510(K)
- K893613STATSPIN MINI-PLASMA2Cleared 510(K)
- K890109SAFEPETTE DISPENSER2Cleared 510(K)
- K884807LIPOCLEAR LIPEMIA CLEARING REAGENT2Cleared 510(K)
- K884111PUMPETTE(TM)2Cleared 510(K)
- K883813CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE2Cleared 510(K)
- K883320MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE2Cleared 510(K)
- K882614MONOJECT(R) SNAP-OVER SAFETY CAP2Cleared 510(K)
- K882539CLEANTECH SYSTEM2Cleared 510(K)
- K881201HR VACUTRAC2Cleared 510(K)
- K880594VACUGUARD(TM)2Cleared 510(K)
- K880622LABCO LIMITED EXETAINER(R)2Cleared 510(K)
- K864866RESUBMISSION OF THE KLEERZIT REAGENT2Cleared 510(K)
- K864863DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)2Cleared 510(K)
- K863976OCEAN SCIENTIFIC VACUTEST2Cleared 510(K)
- K863491BLOOD SPECIMEN COLLECTION DEVICES2Cleared 510(K)
- K853152MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR2Cleared 510(K)
- K851506SERUM TRANSPORT VIALS, T25/SC, TZ10/SC2Cleared 510(K)
- K840496ISOSTAT MICROBIAL TUBE PROCESSING2Cleared 510(K)
- K833475CAPIJECT SYS CAPILLARY BLOOD COLLECT2Cleared 510(K)
- K833312ARTERIAL MICRO COLLECTION KIT2Cleared 510(K)
- K831719MONOJET SPS BLOOD COLLECTION TUBE2Cleared 510(K)
- K830472LIPOSOL2Cleared 510(K)
- K831242LITHIUM HEPARINIZED BLOOD COLLECT-TUBE2Cleared 510(K)
- K831081EZEE FILTER/SEPARATOR2Cleared 510(K)
- K823836MONOJECT SAMPLETTE CAPILLARY BLOOD COLL2Cleared 510(K)
- K823176MONOJECT SAMPLETTE CAPILLARY SERUM SEP2Cleared 510(K)
- K822508MINISAMPLER TM2Cleared 510(K)
- K820717MONOJECT CORVAC STAT VAC TUBE W/THROM2Cleared 510(K)
- K812285MONOJECT STERILE CORVAC BLOOD TUBE2Cleared 510(K)
- K811036FILTER SAMPLER BLOOD SERUM FILTER2Cleared 510(K)
- K810816PREFILLED ARTERIAL BLOOD SAMPLING SYRING2Cleared 510(K)
- K810664ISOLATOR SYSTEM2Cleared 510(K)
- K802211SERUM SEPARATOR2Cleared 510(K)
- K802209SURETY COLUMN2Cleared 510(K)
- K792723BLOOD FLUID FILTERS2Cleared 510(K)
- K792587VENOJECT AUTOSEP2Cleared 510(K)
- K791303DORN BLOOD CULTURE COLLECTION TUBE2Cleared 510(K)
- K790485AMYLOCHROME STAT SEPARATOR, TEST2Cleared 510(K)
- K781629SERI-SEP SERUM/PLASMA ISLOLATOR2Cleared 510(K)
- K770107SERI-SEP2Cleared 510(K)
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- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)1Product Code
- JKDRadioimmunoassay, C-Peptides Of Proinsulin1Product Code
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge1Product Code
- JKGL-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase1Product Code
- JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen1Product Code
- JKJFluorometric Measurement, Porphyrins1Product Code
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry1Product Code
- JKPChromium-51, Blood Volume1Product Code
- JKRRadioimmunoassay, Calcitonin2Product Code
- JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKYOxalydihydrazide (Spectroscopic), Copper1Product Code
- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
- JLAConversion To Creatinine, Creatine1Product Code
- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
- JLCNitroprusside Reaction (Qualitative, Urine), Cystine1Product Code
- JLDChromatographic, Cystine1Product Code
- JLERadioimmunoassay, Desoxycorticosterone1Product Code
- JLFRadioimmunoassay, Etiocholanolone1Product Code
- JLGConversion To Ferric Hydroxymates (Colorimetric), Fatty Acids1Product Code
- JLHTitrimetric, Fatty Acids1Product Code
- JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid1Product Code
- JLJUridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate2Product Code
- JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity1Product Code
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- JLOEnzymatic (Glutathione Reductase), Glutathione1Product Code
- JLPSpectrophotometric Method, Pregnanediol1Product Code
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- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
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- JNGRadioimmunoassay, Pregnenolone1Product Code
- JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase1Product Code
- JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase1Product Code
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin1Product Code
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1Product Code
- JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)1Product Code
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)1Product Code
- JNSStannous Chloride - Hydrazine, Phospholipids1Product Code
- JNTChromatographic, Phospholipids1Product Code
- JNXMembrane Osmometry, Plasma Oncometry1Product Code
- JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase1Product Code
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- JOBHexane Extraction, Fluorescence, Vitamin E1Product Code
- JOCColorimetric, Xylose1Product Code
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQAElectrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes1Product Code
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity1Product Code
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- JQIRotating Disc, Plasma Viscometry1Product Code
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- KHQRadioassay, Triiodothyronine Uptake2Product Code
- KHSEnzymatic, Carbon-Dioxide2Product Code
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- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
- KQNRadioassay, Angiotensin Converting Enzyme2Product Code
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- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
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- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
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- LFPConductivity Rate, Urea Nitrogen2Product Code
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- LFRGlucose Dehydrogenase, Glucose2Product Code
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- LPWSystem, Test, Oxalate1Product Code
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- MRRSystem, Test, Low Density, Lipoprotein1Product Code
- MRVDrink, Glucose Tolerance2Product Code
- MSJApolipoproteins1Product Code
- MSMSystem, Test, Lipoprotein(A)1Product Code
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- MZVTest, System, Potassium, Enzymatic Method2Product Code
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- NALTest, Immunoassay, Biosensor, Hcg2Product Code
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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K-SHIELD Zen
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K220799
- 510(k) Type
- Traditional
- Applicant
- Sb-Kawasumi Laboratories, Inc.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/29/2022
- Days to Decision
- 164 days
- Submission Type
- Summary