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
- K172903HemosIL D-Dimer HS 5002Cleared 510(K)
- K162227STA® - Liatest® D-Di2Cleared 510(K)
- K160885HemosIL D-Dimer HS2Cleared 510(K)
- K151534HemosIL D-Dimer HS2Cleared 510(K)
- K141144STA LIATEST D-DI2Cleared 510(K)
- K112818VIDAS D-DIMER EXCLUSION II (DEX2)2Cleared 510(K)
- K110303STRATUS CS ACUTE CARE D-DIMER2Cleared 510(K)
- K093626INNOVANCE D-DIMER, MODEL OPBP092Cleared 510(K)
- K090264HEMOSIL D-DIMER HS 500, CONTROLS2Cleared 510(K)
- K091916INNOVANCE D-DIMER, MODEL OPBP092Cleared 510(K)
- K081732INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS2Cleared 510(K)
- K073042HEMOSIL D-DIMER2Cleared 510(K)
- K080069DIMERTEST2Cleared 510(K)
- K070927HEMOSIL D-DIMER HS2Cleared 510(K)
- K063356STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK2Cleared 510(K)
- K051597STRATUS CS D-DIMER2Cleared 510(K)
- K050544HEMOSIL D-DIMER HS2Cleared 510(K)
- K050278HEMOSIL D-DIMER2Cleared 510(K)
- K042723TRIGAGE PROFILER S.O.B. PANEL, MODEL 973002Cleared 510(K)
- K033491ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS2Cleared 510(K)
- K041438ADVANCED D-DIMER ASSAY2Cleared 510(K)
- K040437TRIAGE PROFILER S.O.B. PANEL2Cleared 510(K)
- K040882VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 4422Cleared 510(K)
- K032419QUANTEX D-DIMER2Cleared 510(K)
- K030328VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 4422Cleared 510(K)
- K030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C2Cleared 510(K)
- K022976STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D2Cleared 510(K)
- K022977STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C2Cleared 510(K)
- K020810VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 4422Cleared 510(K)
- K012755AUTODIMER ASSAY MODEL # 14312Cleared 510(K)
- K013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A79712Cleared 510(K)
- K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A82212Cleared 510(K)
- K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A80962Cleared 510(K)
- K002948K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT2Cleared 510(K)
- K002706ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI2Cleared 510(K)
- K003267SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A2Cleared 510(K)
- K002642MINIQUANT D-DIMER, MODEL 14472Cleared 510(K)
- K000492MDA D-DIMER2Cleared 510(K)
- K992957ADVANCED D-DIMER2Cleared 510(K)
- K974596DIMERTEST LATEX ASSAY2Cleared 510(K)
- K974776MDA D-DIMER2Cleared 510(K)
- K973819VIDAS D-DIMER (DD) ASSAY2Cleared 510(K)
- K972696IL TEST D-DIMER2Cleared 510(K)
- K964728STA-LIATEST D-DI TEST KIT2Cleared 510(K)
- K964718STA D-DI CALIBRATOR KIT2Cleared 510(K)
- K943571MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS2Cleared 510(K)
- K943787AURATEK FDP2Cleared 510(K)
- K932657FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 22Cleared 510(K)
- K915698FIBRINOSTIKA TDP MICROELISA SYSTEM2Cleared 510(K)
- K920943FDP PLASMA TEST KIT2Cleared 510(K)
- K915203D-DIMER WELLCOTEST (HA10)2Cleared 510(K)
- K915503FIBRINOGEN FDP CONTROL2Cleared 510(K)
- K912876FIBRINOSTIKA FBDP MICROELISA SYSTEM2Cleared 510(K)
- K890189AGEN DIMERTEST EIA2Cleared 510(K)
- K882944DIMERTEST(R) LATEX2Cleared 510(K)
- K872195DATA-FI DIMERTEST LATEX ASSAY2Cleared 510(K)
- K862156ASSERACHROM D-DI KIT2Cleared 510(K)
- 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
AUTODIMER ASSAY MODEL # 1431
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K012755
- 510(k) Type
- Traditional
- Applicant
- Xtrana, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/15/2002
- Days to Decision
- 211 days
- Submission Type
- Statement