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
- K253188CoaguChek XS Plus System2Cleared 510(K)
- K251564microINR System2Cleared 510(K)
- K243543microINR System2Cleared 510(K)
- K230802Xprecia Prime Coagulation System2Cleared 510(K)
- K220282i-STAT PTplus Cartridge with the i-STAT 1 System2Cleared 510(K)
- K231711microINR System2Cleared 510(K)
- K211485STA- NeoPTimal2Cleared 510(K)
- K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing2Cleared 510(K)
- K213426HemosIL ReadiPlasTin2Cleared 510(K)
- K201185microINR System2Cleared 510(K)
- K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring Device2Cleared 510(K)
- K180780microINR System2Cleared 510(K)
- K180693CoaguChek XS Pro System2Cleared 510(K)
- K180684CoaguChek XS Plus System2Cleared 510(K)
- K170960CoaguChek Vantus System2Cleared 510(K)
- K151964Xprecia Stride Coagulation System, Xprecia System PT Controls2Cleared 510(K)
- K132722HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)2Cleared 510(K)
- K122584HEMOSIL READIPLAS TIN2Cleared 510(K)
- K110212INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP2Cleared 510(K)
- K092987INRATIO/INRATIO2 TEST STRIPS2Cleared 510(K)
- K093243COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM2Cleared 510(K)
- K093460COAGUCHEK XS PRO SYSTEM2Cleared 510(K)
- K092940COAGUCHEK XS PLUS PST SYSTEM2Cleared 510(K)
- K072920HANDHELD BASE UNIT2Cleared 510(K)
- K072727INRATIO 2 PT MONITORING SYSTEM2Cleared 510(K)
- K070005HEMOSIL RECOMBIPLASTIN 2G2Cleared 510(K)
- K071041COAGUCHEK XS PLUS SYSTEM2Cleared 510(K)
- K062925COAGUCHEK XS SYSTEM2Cleared 510(K)
- K060978COAGUCHEK XS SYSTEM2Cleared 510(K)
- K060931HEMOSIL PT-FIBRINOGEN HS PLUS2Cleared 510(K)
- K052124ACTICLOT, MODEL 8242Cleared 510(K)
- K043184HEMOSIL RECOMBIPLASTIN2Cleared 510(K)
- K040296PHOSPHOPLASTIN RL2Cleared 510(K)
- K030845COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING2Cleared 510(K)
- K021190PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 20324222Cleared 510(K)
- K021923INRATIO SELF-TEST2Cleared 510(K)
- K020831PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 32714042Cleared 510(K)
- K022922HARMONY INR MONITORING SYSTEM2Cleared 510(K)
- K020840VITAL SCIENTIFIC PT WITH CALCIUM2Cleared 510(K)
- K020355I-STAT PROTHROMBIN TIME TEST2Cleared 510(K)
- K020679INRATIO2Cleared 510(K)
- K013155DADE THROMBOPLASTIN C PLUS2Cleared 510(K)
- K012768HEMOSIL RECOMBI PLASTIN2Cleared 510(K)
- K010599PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE2Cleared 510(K)
- K001699RUBICON PROTHROMBIN TIME MONITORING SYSTEM2Cleared 510(K)
- K003870THROMBOREL S2Cleared 510(K)
- K994100PACIFIC HEMOSTASIS THROMBOPLASTIN D2Cleared 510(K)
- K994006AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)2Cleared 510(K)
- K991286AVOCET ACUSURE SYSTEM2Cleared 510(K)
- K992492PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM2Cleared 510(K)
- K991065CARESIDE PT2Cleared 510(K)
- K972866HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT2Cleared 510(K)
- K974343DADE INNOVIN2Cleared 510(K)
- K981479IL TEST PT-FIBRINOGEN RECOMBINANT2Cleared 510(K)
- K974566MDA SIMPLASTIN HTF2Cleared 510(K)
- K972796SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM2Cleared 510(K)
- K962571COAGUCHEK PST SYSTEM2Cleared 510(K)
- K961835PROTIME MICROCOAGULATION SYSTEM2Cleared 510(K)
- K961938STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS2Cleared 510(K)
- K955843TAS PTONE2Cleared 510(K)
- K954625PROTHROMBIN TIME TEST CARD2Cleared 510(K)
- K951820THROMBOPLASTIN-LI REAGENT2Cleared 510(K)
- K952608MDA SIMPLASTIN LS2Cleared 510(K)
- K942884COAGUCHEK SYSTEM2Cleared 510(K)
- K945078HEMOCHRON HNPT/FACTOR VI PT+2Cleared 510(K)
- K935748ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT2Cleared 510(K)
- K940082THROMBOSCREEN THROMBOPLASTIN-DS2Cleared 510(K)
- K935702DADE INNOVIN II2Cleared 510(K)
- K940432MICROCOAGULATION PROTHROMBIN TIME TEST2Cleared 510(K)
- K940310HELENA THROMBOPLASTIN-MI REAGENT2Cleared 510(K)
- K931117ASSESS(TM) LOW ABNORMAL CONTROL2Cleared 510(K)
- K931118ASSESS(TM) HIGH ABNORMAL CONTROL2Cleared 510(K)
- K933252IL TEST (TM) PT-FIBRINOGEN HS PLUS2Cleared 510(K)
- K930212THROMBOPLATIN-M WITH CALCIUM2Cleared 510(K)
- K925604ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT2Cleared 510(K)
- K920767NYCOPLASTIN2Cleared 510(K)
- K925492BIOMERIEUX HEMOLAB THROMBOMAT2Cleared 510(K)
- K922565NEOPLASTINE(R) CI KIT2Cleared 510(K)
- K921326DADE RECOMBOPLASTIN S2Cleared 510(K)
- K922040NEOPLASTINE CI PLUS2Cleared 510(K)
- K915746SIMPLASTIN L2Cleared 510(K)
- K913249ACS ULTRA-1 THROMBOPLASTIN2Cleared 510(K)
- K913250ACS ULTRA-2 THROMBOPLASTIN2Cleared 510(K)
- K912102ACS LIQUID THROMBOPLASTIN2Cleared 510(K)
- K911995PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION2Cleared 510(K)
- K905807HELENA THROMBOPLASTIN REAGENT WITH DILUENT2Cleared 510(K)
- K905857HELENA THROMBOPLASTIN REAGENT, MODIFICATION2Cleared 510(K)
- K904325COAG-1 PT-NC TEST CARD2Cleared 510(K)
- K904454HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION2Cleared 510(K)
- K902468ACS ONE-STAGE PROTHROMBIN TIME REAGENT2Cleared 510(K)
- K903019MODIFIED COAG-1 PT TEST CARD2Cleared 510(K)
- K902096THROMBOPLASTIN WITH CALCIUM2Cleared 510(K)
- K901325THROMBOPLASTIN.C PLUS2Cleared 510(K)
- K896625THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.2Cleared 510(K)
- K885107THROMBOSTIN IFA*2Cleared 510(K)
- K893378PROTHROMBIN TIME (PT) BY HEMOCHRON2Cleared 510(K)
- K892050HELENA THROMBOPLASTIN REAGENT2Cleared 510(K)
- K891370EDL ONE-STAGE PROTHROMBIN TIME REAGENT2Cleared 510(K)
- K891169DADE THROMBOPLASTIN IS2Cleared 510(K)
- K884855THROMBOPLASTIN2Cleared 510(K)
- K883441VISION(R) PROTHROMBIN TIME2Cleared 510(K)
- K882456COAG-I PT TEST CARD2Cleared 510(K)
- K882214SIMPLASTIN EXCEL S2Cleared 510(K)
- K880566CLP PROTHROMBIN TIME TEST2Cleared 510(K)
- K875062EASY-TEST PROTHROMBIN TIME PT ITEM NO. 166282Cleared 510(K)
- K874592THROMBOPLASTIN.C2Cleared 510(K)
- K872537PROTHROMBIN TIME TEST2Cleared 510(K)
- K872844THROMBOREL S2Cleared 510(K)
- K870596PROTHROMBIN TIME TEST2Cleared 510(K)
- K864392PROTIME AUTOMATE TEST KIT2Cleared 510(K)
- K864283SIMPLASTIN EXCEL2Cleared 510(K)
- K864273THROMBOPLASTIN.C2Cleared 510(K)
- K864274THROMBOPLASTIN.R2Cleared 510(K)
- K864272THROMBOPLASTIN.FS2Cleared 510(K)
- K860721BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST2Cleared 510(K)
- K852484PLASTINEX2Cleared 510(K)
- K851125ACA PROTHROMBIN TIME ANALYTICAL TEST PACK2Cleared 510(K)
- K843535ORTHO BRAIN THROMBOPLASTIN DILUENT2Cleared 510(K)
- K840802DIA THROMBIN DIA PLASTIN2Cleared 510(K)
- K832427EASYTOUCH TROMBOPLASTIN REAGENT2Cleared 510(K)
- K830331LIQUID THROMBOPLASTIN REAGENT2Cleared 510(K)
- K811784SIGMA PROCEDURE #8902Cleared 510(K)
- K810350THROMBOPLASTIN2Cleared 510(K)
- K792031LANCER COAGENT PT KIT2Cleared 510(K)
- K791022PROTHROMBIN REFERENCE PLASMA (HUMAN)2Cleared 510(K)
- K791023PROTHROMBIN FREE BEEF PLASMA (PFB)2Cleared 510(K)
- K780203THROMBOPLASTIN DRIED2Cleared 510(K)
- 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
- 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
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K905807
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/1991
- Days to Decision
- 110 days