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
- 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)
- K940490DV TEST AND DVV CONFIRM1Cleared 510(K)
- K932463BIOCLOT LA1Cleared 510(K)
- K922326LUPO-TEST REGEANT1Cleared 510(K)
- K922156LUCOR CONFIRMATORY REAGENT1Cleared 510(K)
- K903037LUPO-TEST REAGENT1Cleared 510(K)
- K841365DIA REPTIN1Cleared 510(K)
- 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
- 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
DV TEST AND DVV CONFIRM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K940490
- 510(k) Type
- Traditional
- Applicant
- AMERICAN DIAGNOSTICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/5/1995
- Days to Decision
- 426 days
- Submission Type
- Statement