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
- K242952INNOVANCE Antithrombin2Cleared 510(K)
- K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO52Cleared 510(K)
- K070301HEMOSIL ANTITHROMBIN2Cleared 510(K)
- K062431HEMOSIL LIQUID ANTITHROMBIN2Cleared 510(K)
- K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 2211052Cleared 510(K)
- K033775HEMOSIL LIQUID ANTITHROMBIN XL2Cleared 510(K)
- K023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 502Cleared 510(K)
- K022550COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS2Cleared 510(K)
- K022195COAMATIC AT-4002Cleared 510(K)
- K994238IL TEST LIQUID ANTITHROMBIN2Cleared 510(K)
- K000361K-ASSAY AT-III2Cleared 510(K)
- K980499IL TEST ANTITHROMBIN2Cleared 510(K)
- K974110IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT2Cleared 510(K)
- K972144SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III2Cleared 510(K)
- K960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)2Cleared 510(K)
- K952515COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY2Cleared 510(K)
- K951943CHROM Z CHROMOGENIC ASSAYS2Cleared 510(K)
- K944279AT-III CALIBRATOR2Cleared 510(K)
- K934156BIOMERIEUX HEMOLAB AT III2Cleared 510(K)
- K935308ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY2Cleared 510(K)
- K936196ANTITHROMBIN III CHROMOGENIC ASSAY2Cleared 510(K)
- K931420COATEST(R) ANTITHROMBIN III, MODIFICATION2Cleared 510(K)
- K915083COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY2Cleared 510(K)
- K913667ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT2Cleared 510(K)
- K905110LIATEST(R) AT III TEST KIT2Cleared 510(K)
- K902393COACUTE ANTITHROMBIN CHROMOGENIC ASSAY2Cleared 510(K)
- K902530SPECTROLYSE ATIII KIT2Cleared 510(K)
- K901977BECKMAN ANTITHROMBIN III REAGENT KIT2Cleared 510(K)
- K900400ORTHOKROME* ANTITHROMBIN2Cleared 510(K)
- K893608ACTICHROME ATIII KIT2Cleared 510(K)
- K884144TURBOX ANTITHROMBIN III2Cleared 510(K)
- K883662BERICHROM(R) ANTITHROMBIN III2Cleared 510(K)
- K880700ENZYGNOST(R) TAT REAGENTS2Cleared 510(K)
- K880315DADE ANTITHROMBIN III CHROMOGENIC ASSAY2Cleared 510(K)
- K864214IL TEST 97574-15M, ANTITTHROMBIN III ASSASY2Cleared 510(K)
- K850412GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY2Cleared 510(K)
- K841736IL TEST ANTITHROMBIN III ACTIVITY2Cleared 510(K)
- K832592DIACROM * ATIII2Cleared 510(K)
- K832268RABBIT ANTI-HUMAN ANTITHROMBIN III2Cleared 510(K)
- K831961IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN2Cleared 510(K)
- K831297PROTOTRO/PROTEOLYTIC ENZYME CONTROL2Cleared 510(K)
- K812829COATEST ANTITHROMBIN2Cleared 510(K)
- K812626ACA ANTITHROMBIN III PLASMINOGEN CALIB2Cleared 510(K)
- K812627ACA ANTITHROMBIN III TEST PACK2Cleared 510(K)
- K812215ANTITHROMBIN III SCREEN KIT2Cleared 510(K)
- K802912HELENA AT-III QUIPLATE PROCEDURE2Cleared 510(K)
- K792019PHADECODE XA INHIBITOR ASSAY2Cleared 510(K)
- K790090DETERMINATION OF ANTITHROMBIN III, 8852Cleared 510(K)
- K781860ASSAY, CHROMOGENIC ANTITHROMBIN III2Cleared 510(K)
- K781480ANTITHROMBIN III ASSAY2Cleared 510(K)
- K781026ANTITHROMBIN III SERUM, ANTI-HUMAN2Cleared 510(K)
- K772328LAS-R HUMAN ANTITHROMBIN III TEST2Cleared 510(K)
- K780002ANTITHROMBIN III ASSAY2Cleared 510(K)
- K771669DIAG. KIT FOR TOTAL ANTITHROMBIN III2Cleared 510(K)
- K770942PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY2Cleared 510(K)
- K770394THROMBO-SCREEN AT-111 KIT2Cleared 510(K)
- 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
CHROM Z CHROMOGENIC ASSAYS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K951943
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/13/1995
- Days to Decision
- 201 days
- Submission Type
- Statement