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
- 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
- K213464HemosIL Liquid Anti-Xa2Cleared 510(K)
- K162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls2Cleared 510(K)
- K111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH2Cleared 510(K)
- K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS2Cleared 510(K)
- K050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 62Cleared 510(K)
- K013305ENOXAPARIN TEST CARD2Cleared 510(K)
- K013637ACTICHROME HEPARIN (ANTI-FIIA)2Cleared 510(K)
- K013318ACTICHROME HEPARIN (ANTI-FXA), MODEL 8322Cleared 510(K)
- K010455ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN2Cleared 510(K)
- K010193HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS2Cleared 510(K)
- K983178COAMATIC HEPARIN2Cleared 510(K)
- K980242IL TEST HEPARIN2Cleared 510(K)
- K972209SPECTROLYSE HEPARIN (ANTI-IIA)2Cleared 510(K)
- K965076MDA HEPARIN ANTI-X ASSAY2Cleared 510(K)
- K952667CHROM Z-HEPARIN, CAT. NO 52422Cleared 510(K)
- K952514COACUTE HEPARIN2Cleared 510(K)
- K943519HBPM/LMWH CONTROL KIT2Cleared 510(K)
- K943514THE HEPANORM HBPM/LMWH KIT2Cleared 510(K)
- K943520HEPARIN CONTROL KIT2Cleared 510(K)
- K943516ROTACHROM HBPM/LMWH TEST KIT2Cleared 510(K)
- K943515ROTACHROM HEPARIN TEST KIT2Cleared 510(K)
- K925433THE STACHROM HEPARIN ASSAY KIT2Cleared 510(K)
- K943517STACLOT HEPARIN TEST KIT2Cleared 510(K)
- K943283HEPARIN MANAGEMENT TEST CARD; HMT CARD2Cleared 510(K)
- K934274HEMOLAB HEPARICHROM ASSAY2Cleared 510(K)
- K935212IL TEST HEPARIN (XA), PN 84699-152Cleared 510(K)
- K923499SPECTROLYSE HEPARIN KIT2Cleared 510(K)
- K925200BERICHROM HEPARIN2Cleared 510(K)
- K910181HITT BY HEMOCHRON(R)2Cleared 510(K)
- K910741HEPARIN CONTROLS, HIGH AND LOW2Cleared 510(K)
- K904003HEMOCHRON(R) HEPARIN RESPONSE TEST2Cleared 510(K)
- K903841ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA2Cleared 510(K)
- K901874COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY2Cleared 510(K)
- K900396ORTHOKROME* HEPARIN2Cleared 510(K)
- K884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES2Cleared 510(K)
- K864211IL TEST 97575-15, HEPARIN ASSAY2Cleared 510(K)
- K854762HEPANORM CALIBRATION PLASMA SET2Cleared 510(K)
- K853239HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY2Cleared 510(K)
- K850486GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY2Cleared 510(K)
- K843201HEPARIN ACA ANALYTICAL TEST PACK2Cleared 510(K)
- K843202HEPARIN CALIBRATOR ACA2Cleared 510(K)
- K834024HEPARINOMETER2Cleared 510(K)
- K833891COATEST HEPARIN2Cleared 510(K)
- K832373DIACROM * HEPARIN2Cleared 510(K)
- K812424CI-TROL HEPARIN CONTROLS, LOW/HIGH2Cleared 510(K)
- K781479HEPARIN ASSAY2Cleared 510(K)
- 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
SPECTROLYSE HEPARIN KIT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K923499
- 510(k) Type
- Traditional
- Applicant
- BIOPOOL AB
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/27/1994
- Days to Decision
- 561 days
- Submission Type
- Statement