Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- GKKCyanomethemoglobin2Product Code
- GIQHemoglobin S2Product Code
- GISTest, Fibrinogen2Product Code
- GITReagent & Control, Partial Thromboplastin Time2Product Code
- GJATest, Thrombin Time2Product Code
- GJBThrombin2Product Code
- GJCAssay, Sulfhemoglobin2Product Code
- GJSTest, Time, Prothrombin2Product Code
- GJTPlasma, Coagulation Factor Deficient2Product Code
- GJZCyanomethemoglobin Reagent And Standard Solution2Product Code
- GKAAbnormal Hemoglobin Quantitation2Product Code
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control2Product Code
- DARFibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control2Product Code
- DATFibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAXFibrinogen And Split Products, Fitc, Antigen, Antiserum, Control2Product Code
- DAZFibrinogen And Split Products, Antigen, Antiserum, Control2Product Code
- DDQAntigen, Antiserum, Control, Antithrombin Iii2Product Code
- GFKFibrinogen Determination Standards And Controls2Product Code
- GFOActivated Partial Thromboplastin2Product Code
- GFTProtamine Sulphate2Product Code
- GFXFibrinogen Standard2Product Code
- GGFAcid Hematin2Product Code
- GGOReagent, Thromboplastin And Control2Product Code
- GGPTest, Qualitative And Quantitative Factor Deficiency2Product Code
- K230852HemosIL Chromogenic Factor IX2Cleared 510(K)
- K220728vWF Ag2Cleared 510(K)
- K214002CRYOcheck Chromogenic Factor IX2Cleared 510(K)
- K223402HemosIL von Willebrand Factor Antigen2Cleared 510(K)
- K200033HemosIL von Willebrand Factor Antigen2Cleared 510(K)
- K193204Cryocheck Chromogenic Factor VIII2Cleared 510(K)
- K183440CRYOcheck FVIII Inhibitor Kit2Cleared 510(K)
- K181525INNOVANCE Free PS Ag2Cleared 510(K)
- K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAY2Cleared 510(K)
- K102164HEMOSIL PROTEIN S ACTIVITY ASSAY2Cleared 510(K)
- K092170STA LIATEST FREE PS2Cleared 510(K)
- K082631THROMBO TEK PSE, MODEL 90-4802Cleared 510(K)
- K082205FACTOR VIII ANTIBODY SCREEN2Cleared 510(K)
- K063323SPECTROLYSE PAI-1, MODEL 1012012Cleared 510(K)
- K070635HEMOSIL PROCLOT2Cleared 510(K)
- K062530TRIAGE PROTEIN C TEST2Cleared 510(K)
- K062430HEMOSIL PROTEIN C2Cleared 510(K)
- K052825VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG2Cleared 510(K)
- K053499HEMOSIL PROS2Cleared 510(K)
- K050365BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 2212022Cleared 510(K)
- K050448CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 52Cleared 510(K)
- K051054VISULIZE FACTOR IX ANTIGEN KIT2Cleared 510(K)
- K043571CRYOCHECK CLOT S2Cleared 510(K)
- K042576COATEST SP FVIII2Cleared 510(K)
- K040987CRYOCHECK CLOT C2Cleared 510(K)
- K040843HEMOSIL VON WILLEBRAND ACTIVITY2Cleared 510(K)
- K032139REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 108262Cleared 510(K)
- K033631MODIFICATION TO COATEST FACTOR VIII2Cleared 510(K)
- K023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 502Cleared 510(K)
- K022290PROTEIN S AC2Cleared 510(K)
- K013492IMUBIND TPA ELISA, MODEL 8602Cleared 510(K)
- K013168IMUBIND PLASMA PAI-1 ELISA,MODEL 8222Cleared 510(K)
- K012386ACTICLOT PROTEIN S, MODEL 843L2Cleared 510(K)
- K011424IL TEST PROS2Cleared 510(K)
- K010963STA-LIATEST FREE PROTEIN S TEST KIT2Cleared 510(K)
- K010379IL TEST FREE PROTEIN S2Cleared 510(K)
- K002467COALIZA PROTEIN S-FREE2Cleared 510(K)
- K002350REFACTO LABORATORY STANDARD2Cleared 510(K)
- K002541PROTEIN C REAGENT2Cleared 510(K)
- K000649SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-15002Cleared 510(K)
- K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 2002Cleared 510(K)
- K993553GTI-FVIII INHIBITOR ASSAY2Cleared 510(K)
- K992704IL TEST VON WILLEBRAND FACTOR2Cleared 510(K)
- K983898BIOCLOT APC SENSITIVITY2Cleared 510(K)
- K983914REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT2Cleared 510(K)
- K983107VFE2Cleared 510(K)
- K981817COAMATIC PLASMIN INHIBITOR2Cleared 510(K)
- K981696IL TEST PLASMIN INHIBITOR2Cleared 510(K)
- K980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY2Cleared 510(K)
- K981200IL TEST PLASMINOGEN2Cleared 510(K)
- K974711COAMATIC PLASMINOGEN2Cleared 510(K)
- K980875IL TEST PROTEIN C2Cleared 510(K)
- K981038COAMATIC FACTOR VIII2Cleared 510(K)
- K971985N-ASSAY TIA PLASMINOGEN TEST KIT2Cleared 510(K)
- K972342REAADS PROTEIN C ANTIGEN TEST KIT2Cleared 510(K)
- K973143UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA2Cleared 510(K)
- K971519ASSERACHROM TPA TEST KIT2Cleared 510(K)
- K972482REAADS PROTEIN S ANTIGEN TEST KIT2Cleared 510(K)
- K972005REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT2Cleared 510(K)
- K972116VON WILLEBRAND REAGENT2Cleared 510(K)
- K972288FACTOR DEFICIENT PLASMAS - FACTOR IX (9)2Cleared 510(K)
- K951640HUMAN PROTEIN S RID TEST KIT2Cleared 510(K)
- K964459UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K964270UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K962968PROC APC ASSAY, PROC CONTROL PLASMA2Cleared 510(K)
- K963106CHROMOLIZE PAI-1 KIT2Cleared 510(K)
- K962825SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY2Cleared 510(K)
- K961929FACTOR DEFICIENT PLASMA2Cleared 510(K)
- K962489CHROMOLIZE TPA ASSAY KIT2Cleared 510(K)
- K960438TINTELIZE PAI-1 KIT2Cleared 510(K)
- K955738BIOCLOT PROTEIN S2Cleared 510(K)
- K952126AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II2Cleared 510(K)
- K952668CHROM Z-F:VIII, CAT. NO. 52412Cleared 510(K)
- K952666CHROM Z-PROTEIN C, CAT. NO. 52432Cleared 510(K)
- K952669CHROM Z-PLASMINOGEN, CAT. NO. 52442Cleared 510(K)
- K954040ASSERACHROM TOTAL PROTEIN S KIT2Cleared 510(K)
- K954017ASSERACHROM FREE PROTEIN S KIT2Cleared 510(K)
- K943225COAMATIC FACTOR VIII2Cleared 510(K)
- K941752SPECTROLYSE ANTIPLASMIN KIT2Cleared 510(K)
- K942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES2Cleared 510(K)
- K950015HUMAN PROTEIN C RID TEST KIT2Cleared 510(K)
- K924425PROTEIN C REAGENT, COAGULOMETRIC2Cleared 510(K)
- K945414RISTOCETIN COFACTOR ASSAY KIT2Cleared 510(K)
- K934210HEMOLAB PROTEIN C CHROMOGENIC ASSAY2Cleared 510(K)
- K934314TINTELIZER(R) TPA2Cleared 510(K)
- K925617MDA PROTEIN ASSAY2Cleared 510(K)
- K934584SPECTROLYSE FACTOR VII:C2Cleared 510(K)
- K931906NEW STACHROM PROTEIN C TEST KIT2Cleared 510(K)
- K930235HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY2Cleared 510(K)
- K930327IL TEST(TM) PROTEIN S2Cleared 510(K)
- K924884IL TEST(TM) PRO-CHROM2Cleared 510(K)
- K922201COAMATE PROTEIN C CHROMOGENIC ASSAY2Cleared 510(K)
- K922782SPECTROLYSE/PL PAI KIT2Cleared 510(K)
- K921449NEW STACHROM ANTIPLASMIN2Cleared 510(K)
- K920012IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM2Cleared 510(K)
- K920981RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA2Cleared 510(K)
- K914818DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY2Cleared 510(K)
- K915163PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES2Cleared 510(K)
- K914307SPECTROLYSE PROTEIN C KIT2Cleared 510(K)
- K912711IL TEST PROCLOT ASSAY STYSTEM2Cleared 510(K)
- K913424STACLOT(R) PROTEIN S TEST KIT2Cleared 510(K)
- K912468LIATEST PROTEIN S KIT2Cleared 510(K)
- K912025SPECTROLYSE PLASMINOGEN SK KIT2Cleared 510(K)
- K903468DADE PROTEIN C CLOTTING ASSAY2Cleared 510(K)
- K904247FREE PROTEIN S REAGENT CAT. NO. 53632Cleared 510(K)
- K902566BIOPOOL PROTEIN C EID KIT AND BULK PLATES2Cleared 510(K)
- K902528BIOCLOT C KIT2Cleared 510(K)
- K900399ORTHOKROME* PLASMINOGEN2Cleared 510(K)
- K900395ORTHOKROME* FACTOR VIII2Cleared 510(K)
- K900398ORTHOKROME* PROTEIN C2Cleared 510(K)
- K900397ORTHOKROME* ANTIPLASMIN2Cleared 510(K)
- K896174PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 53592Cleared 510(K)
- K897136PROTEIN C ANTIGEN ROCKET EID METHOD NO. 53572Cleared 510(K)
- K892859THE STAGO VIII DEFICIENT PLASMA KIT2Cleared 510(K)
- K890634BERICHROM PROTEIN C KIT2Cleared 510(K)
- K884797BERICHROM ALPHA-2-ANTIPLASMIN2Cleared 510(K)
- K884940RELLPLATE C KIT, RELLPLATE C BULK PLATES2Cleared 510(K)
- K884941ACTICLOT C KIT2Cleared 510(K)
- K890409DADE(R) PLASMINOGEN CHROMOGENIC ASSAY2Cleared 510(K)
- K884881DADE PROTEIN C CHROMOGENIC ASSAY2Cleared 510(K)
- K884551DADE FACTOR IX CHROMOGENIC ASSAY2Cleared 510(K)
- K884544DADE FACTOR VIII CHROMOGENIC ASSAY2Cleared 510(K)
- K884058COATEST PROTEIN C2Cleared 510(K)
- K882603STACHROM ANTIPLASMIN CONTROL2Cleared 510(K)
- K882602STACHROM ANTIPLASMIN TEST KIT2Cleared 510(K)
- K881037SPECTROLYSE/FIBRIN2Cleared 510(K)
- K874940CALIBRATION REFERENCE PLASMA2Cleared 510(K)
- K874097STACHROM VIII:C TEST KIT2Cleared 510(K)
- K872941SPECTRO C2Cleared 510(K)
- K872479ASSERACHROM PROTEIN S TEST KIT2Cleared 510(K)
- K871039STACHROM PROTEIN C TEST KIT2Cleared 510(K)
- K870917PROTEIN S CONTROL PLASMA2Cleared 510(K)
- K864701VWF IMMUNOBLOT2Cleared 510(K)
- K870354IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)2Cleared 510(K)
- K870353IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)2Cleared 510(K)
- K864480IL TEST 84668-15, FACTOR VIII CONTROL PLASMA2Cleared 510(K)
- K864497COAGULATION EXTRINSIC DEFICIENT PLASMAS2Cleared 510(K)
- K864481COAGULATION INTRINSIC DEFICIENT PLASMAS2Cleared 510(K)
- K861475ASSERA-PLATE PROTEIN C KIT2Cleared 510(K)
- K861417ASSERA-PLATE VWF KIT2Cleared 510(K)
- K861079STACLOT PROTEIN C TEST KIT2Cleared 510(K)
- K861048PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 67652Cleared 510(K)
- K861049HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA2Cleared 510(K)
- K861217VWF-IX:AG CONTROL PLASMA2Cleared 510(K)
- K861216PROTEIN C CONTROL PLASMA2Cleared 510(K)
- K861159SPECTRO VWF2Cleared 510(K)
- K860371ASSERACHROM VWF KIT2Cleared 510(K)
- K854312ASSERACHROM IX:AG2Cleared 510(K)
- K854014ASSERA PLATE IX:AG KIT2Cleared 510(K)
- K853462COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA2Cleared 510(K)
- K853461COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA2Cleared 510(K)
- K843451FACTOR XII DEFICIENT PLASMA B12D2Cleared 510(K)
- K843438FACTOR XI DEFICIENT PLASMA B11D2Cleared 510(K)
- K843310FACTOR X DEFICIENT PLASMA, BLOD HUMAN2Cleared 510(K)
- K843215FACTOR IX DEFICIENT PLASMA, B9D -2Cleared 510(K)
- K842617VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT2Cleared 510(K)
- K841957BOVINE FACTOR XA-HUMAN FACTOR XA2Cleared 510(K)
- K841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII2Cleared 510(K)
- K841461COAGULATION CONTROL PLASMA LEVEL 1/2/32Cleared 510(K)
- K840927FACTOR DEFICIENT SUBSTRATE PLASMA II2Cleared 510(K)
- K840928FACTOR DEFICIENT SUBSTRATE PLASMA VIII2Cleared 510(K)
- K841364COAGULATION FACTOR V DEFICIENT SUBSTR2Cleared 510(K)
- K840329RISTOCETIN COFACTOR ASSAY2Cleared 510(K)
- K840114COAGULATION FACTOR DEFICIENT PLASMA2Cleared 510(K)
- K834050PROTOPATH FACTOR IX ASSAY2Cleared 510(K)
- K834051PROTOPATH FACTOR VIII ASSAY2Cleared 510(K)
- K833892COATEST FACTOR VIII2Cleared 510(K)
- K834031FACTOR II DEFICIENT SUBSTRATE PLASMA2Cleared 510(K)
- K832372DIACROM * FACTOR X KIT HA312Cleared 510(K)
- K832114COATEST FACTOR X2Cleared 510(K)
- K823453VON WILLEBRAND FACTOR ASSAY2Cleared 510(K)
- K823267FACTOR VIII RELATED ANTIGEN ROCKET EID2Cleared 510(K)
- K821963EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.2Cleared 510(K)
- K820085DADE FACTOR ASSAY REFERENCE PLASMA2Cleared 510(K)
- K812975LANCER COAGENT HUMAN VACTOR VIII PLASMA2Cleared 510(K)
- K812974LANCER COAGENT HUMAN FACTOR 1X PLASMA2Cleared 510(K)
- K812431FACTOR VIII DEFICIENT PLASMA #B8D2Cleared 510(K)
- K802356VON WILLEBRAND FACTOR ASSAY2Cleared 510(K)
- K792656HELENA FACTOR XII DEFICIENT2Cleared 510(K)
- K792511HELENA FACTOR VII DEFICIENT SUB. PLASMA2Cleared 510(K)
- K792507HELENA FACTOR V DEFICIENT SUBSTRATE2Cleared 510(K)
- K792508HELENA FACTOR X DEFICIENT SUBSTRATE2Cleared 510(K)
- K792476HELENA FACTOR XI DEFICIENT SUBSTRATE2Cleared 510(K)
- K792475HELENA FACTOR IX DEFICIENT SUBSTRATE2Cleared 510(K)
- K792336HELENA FACTOR II DEFICIENT SUB. PLASMA2Cleared 510(K)
- K792335HELENA FACTOR VIII DEFICIENT SUB. PLASMA2Cleared 510(K)
- K791794FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K790423FACTOR V DEFICIENT2Cleared 510(K)
- K761058QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT2Cleared 510(K)
- GGQTest, Prothrombin Consumption2Product Code
- GGTAssay, Erythropoietin2Product Code
- GGWTest, Time, Partial Thromboplastin2Product Code
- GGZOxyhemoglobin2Product Code
- GHAHemoglobin, Alkali Resistant2Product Code
- GHDTest, Leukocyte Alkaline Phosphatase1Product Code
- GHHFibrin Split Products2Product Code
- GHMTest, Sickle Cell2Product Code
- GHQStain, Fetal Hemoglobin2Product Code
- GHSAssay, Carboxyhemoglobin2Product Code
- GIGHemoglobinometer2Product Code
- GIIGlutathione, Red-Cell2Product Code
- GILPlasma, Fibrinogen Control2Product Code
- GKQTest, Thromboplastin Generation1Product Code
- GLYOximeter To Measure Hemoglobin2Product Code
- JBBSolubility, Hemoglobin, Abnormal2Product Code
- JBDSystem, Analysis, Electrophoretic Hemoglobin2Product Code
- JBECell Enzymes (Erythrocytic And Leukocytic)2Product Code
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening2Product Code
- JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot2Product Code
- JBHGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod2Product Code
- JBIGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition2Product Code
- JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction2Product Code
- JBKGlucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic2Product Code
- JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative2Product Code
- JBMGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis2Product Code
- JBNFibrin Monomer Paracoagulation2Product Code
- JBOTest, Euglobulin Lysis2Product Code
- JBPActivated Whole Blood Clotting Time2Product Code
- JBQAntithrombin Iii Quantitation2Product Code
- JBRTest, Heparin Neutralization2Product Code
- JCJAlkaline Phosphatase1Product Code
- JCMControl, Hemoglobin, Abnormal2Product Code
- JLMIsoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase2Product Code
- JMBVisual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase2Product Code
- JMCNadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase2Product Code
- JMHFluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase2Product Code
- JPBHemoglobin M2Product Code
- JPCHemoglobin F Quantitation2Product Code
- JPDHemoglobin A2 Quantitation2Product Code
- JPEAntithrombin Iii, Two Stage Clotting Time Assay2Product Code
- JPFProthrombin-Proconvertin And Thrombotest2Product Code
- JWRAtp Release (Luminescence)1Product Code
- KFFAssay, Heparin2Product Code
- KHFAdenine Nucleotide Quantitation1Product Code
- KHGWhole Blood Hemoglobin Determination2Product Code
- KQEAssay, Erythrocytic Glucose-6-Phosphate Dehydrogenase2Product Code
- KQFAssay, Glutathione Reductase2Product Code
- KQIAssay, Fetal Hemoglobin2Product Code
- KQJSystem, Fibrinogen Determination2Product Code
- LCOPlatelet Factor 4 Radioimmunoassay2Product Code
- LCPAssay, Glycosylated Hemoglobin2Product Code
- LGLAssay, Bart'S, Hemoglobin2Product Code
- LGOTest, Leukocyte Typing1Product Code
- LIMTest, Screening, For D Positive Fetal Rbc'S2Product Code
- LJXTest, Urine Leukocyte1Product Code
- LKZRed-Cell Count By Photometry2Product Code
- MIFProthrombin Fragment 1.22Product Code
- MLLHemoglobin C (Abnormal Hemoglobin Variant)2Product Code
- NOZAssay, 1,5-Anhydroglucitol (15ag)2Product Code
- ODVVitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System2Product Code
- OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr2Product Code
- PWDFlow Cytometric Test System For Hematopoietic Neoplasms2Product Code
- QGUHemoglobin For Donor Testing2Product Code
- QLUAnti-Factor Xa Activity Test System, Apixaban2Product Code
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K980885
- 510(k) Type
- Traditional
- Applicant
- SHIELD DIAGNOSTICS, LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/21/1998
- Days to Decision
- 165 days
- Submission Type
- Statement