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
- K222831CRYOcheck Factor VIII Deficient Plasma with VWF2Cleared 510(K)
- K180486HemosIL Factor XII Deficient Plasma2Cleared 510(K)
- K102908NOFACT IX2Cleared 510(K)
- K102851NOFACT VIII2Cleared 510(K)
- K110237HEMOSIL FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K050661HEMOSIL FACTOR II DEFICIENT PLASMA2Cleared 510(K)
- K043459HEMOSIL FACTOR XII DEFICIENT PLASMA2Cleared 510(K)
- K040362DIAPHARMA FACTOR X KIT2Cleared 510(K)
- K034007HEMOSIL FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K031829HEMOSIL FACTOR IX DEFICIENT PLASMA2Cleared 510(K)
- K031122HEMOSIL FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K030287HEMOSIL FACTOR XI DEFICIENT PLASMA2Cleared 510(K)
- K024082HEMOSIL FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K023839HEMOSIL FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-152Cleared 510(K)
- K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)2Cleared 510(K)
- K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K981173CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)2Cleared 510(K)
- K981174CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)2Cleared 510(K)
- K981709COAGULATION FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K972627PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)2Cleared 510(K)
- K971223CRYO CHECK FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K971227CRYO CHECK FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K971226CRYO CHECK FACTOR IX DEFICIENT PLASMA2Cleared 510(K)
- K971225CRYO CHECK FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K971224CRYO CHECK FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K972286FACTOR DEFICIENT PLASMAS - FACTOR XI (11)2Cleared 510(K)
- K970607UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K970593UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K962675STA - LIATEST VWF TEST KIT2Cleared 510(K)
- K962671STA-VWF CALIBRATOR KIT2Cleared 510(K)
- K945857PROTEIN C DEFICIENT PLASMA2Cleared 510(K)
- K942049BIOMERIEUX HEMOLAB COFAC II2Cleared 510(K)
- K942050HEMOLAB COFAC IX2Cleared 510(K)
- K935851BIOMERIEUX HEMOLAB COFAC X2Cleared 510(K)
- K935850BIOMERIEUX HEMOLAB COFAC VII2Cleared 510(K)
- K935057FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K935054FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K935058FACTOR2Cleared 510(K)
- K935056FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K934606STAGO FACTOR II-DEFICIENT PLASMA2Cleared 510(K)
- K934605STAGO FACTOR V-DEFICIENT PLASMA2Cleared 510(K)
- K933432STAGO FACTOR IX-DEFICIENT PLASMA2Cleared 510(K)
- K933444STAGO FACTOR XI-DEFICIENT PLASMA2Cleared 510(K)
- K933441STAGO FACTOR X-DEFICIENT PLASMA2Cleared 510(K)
- K933440STAGO FACTOR VII-DEFICIENT PLASMA2Cleared 510(K)
- K933438STAGO FACTOR XII-DEFICIENT PLASMA2Cleared 510(K)
- K933010BIOMERIEUX HEMOLAB COFAC VIII2Cleared 510(K)
- K924400CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA2Cleared 510(K)
- K924396CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA2Cleared 510(K)
- K924394CLOTTING FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K915411DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA2Cleared 510(K)
- K912679DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)2Cleared 510(K)
- K902083CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE2Cleared 510(K)
- K901327ORTHO CORRECTION REAGENTS2Cleared 510(K)
- K900906FACTOR II DEFICIENT PLASMA2Cleared 510(K)
- K900412FACTOR XII DEFICIENT PLASMA2Cleared 510(K)
- K900406FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K900407FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K900408FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K900409FACTOR IX DEFICIENT PLASMA2Cleared 510(K)
- K900410FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K900411FACTOR XI DEFICIENT PLASMA2Cleared 510(K)
- K900133FACTOR II DEFICIENT PLASMA2Cleared 510(K)
- K895504ABNORMAL REFERENCE PLASMA-IX2Cleared 510(K)
- K895503ABNORMAL REFERENCE PLASMA-VIII2Cleared 510(K)
- K893534FACTOR XII DEFICIENT PLASMA2Cleared 510(K)
- K893533FACTOR V DEFICIENT PLASMA2Cleared 510(K)
- K893525FACTOR VIII DEFICIENT PLASMA2Cleared 510(K)
- K893523FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K893524FACTOR IX DEFICIENT PLASMA2Cleared 510(K)
- K893536FACTOR XI DEFICIENT PLASMA2Cleared 510(K)
- K893535FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K883690ORTHO FACTOR X DEFICIENT PLASMA2Cleared 510(K)
- K883692ORTHO FACTOR VII DEFICIENT PLASMA2Cleared 510(K)
- K883691ORTHO FACTOR XI DEFICIENT PLASMA2Cleared 510(K)
- K883688ORTHO FACTOR XII DEFICIENT PLASMA2Cleared 510(K)
- K880874IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN2Cleared 510(K)
- K880292FACTOR VIII REFERENCE PLASMA2Cleared 510(K)
- 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
HEMOLAB COFAC IX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K942050
- 510(k) Type
- Traditional
- Applicant
- BIOMERIEUX VITEK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/1995
- Days to Decision
- 386 days
- Submission Type
- Summary