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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
- Subpart I—Hematology ReagentsCFR Sub-Part
- GIRReagent, Russel Viper Venom1Product Code
- K132130REAGENT, RUSSEL VIPER VENOM - LA SCREEN1Cleared 510(K)
- K132076REAGENT, RUSSEL VIPER VENOM - LA CONFIRM1Cleared 510(K)
- K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM1Cleared 510(K)
- K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA1Cleared 510(K)
- K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM1Cleared 510(K)
- K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A60941Cleared 510(K)
- K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A621191Cleared 510(K)
- K990580CRYOCHECK LA SURE, MODEL SUR25-101Cleared 510(K)
- K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)1Cleared 510(K)
- K990302IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)1Cleared 510(K)
Show All 16 Submissions
- GJNFluid, Diluting, Red-Cell1Product Code
- GJPControl, Platelet2Product Code
- GJRControl, Red-Cell2Product Code
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal2Product Code
- GGJFluid, Diluting, White-Cell1Product Code
- GGKProducts, Red-Cell Lysing Products1Product Code
- GGLControl, White-Cell2Product Code
- GGMControl, Hemoglobin2Product Code
- GIFDiluent, Blood Cell1Product Code
- GLKControl, Hematocrit2Product Code
- GLQMixture, Control, White-Cell And Red-Cell Indices2Product Code
- JCFLymphocyte Separation Medium1Product Code
- JCGFluid, Diluting, Manual Cell1Product Code
- JCNControl, Cell Counter, Normal And Abnormal2Product Code
- JCOBothrops Atrox Reagent2Product Code
- JPKMixture, Hematology Quality Control2Product Code
- KRXCalibrator For Cell Indices2Product Code
- KRYCalibrator For Platelet Counting2Product Code
- KRZCalibrator For Hemoglobin And Hematocrit Measurement2Product Code
- KSACalibrator For Red-Cell And White-Cell Counting2Product Code
- MZGTest, Residual, Wbc In Leukoreduced Blood2Product Code
- NRFMaterial, Quality Control, Semen Analysis2Product Code
- NRSControl Material, Blood Circulating Epithelial Cancer Cell2Product Code
- 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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ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K000528
- 510(k) Type
- Traditional
- Applicant
- SIGMA DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/7/2000
- Days to Decision
- 50 days
- Submission Type
- Summary