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- 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
- K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument2Cleared 510(K)
- K222635Premier Resolution System2Cleared 510(K)
- K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control2Cleared 510(K)
- K180762CAPI 3 HEMOGLOBIN(E)2Cleared 510(K)
- K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software2Cleared 510(K)
- K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM2Cleared 510(K)
- K112491SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 22Cleared 510(K)
- K091283CAPILLARYS NEONAT HB (PN 2006)2Cleared 510(K)
- K082227MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 22272Cleared 510(K)
- K080911VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH2Cleared 510(K)
Show All 23 Submissions
- 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
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- OphthalmicReview Panel
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- UnknownReview Panel
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192931
- 510(k) Type
- Traditional
- Applicant
- Helena Laboratories, Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/19/2022
- Days to Decision
- 915 days
- Submission Type
- Summary