BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)

    K Number: K990579 · Decision Jul 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    10
    Review Days
    150

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
    K Number
    K990579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precision Biologic
    Date Received
    February 23, 1999
    Decision Date
    July 23, 1999
    Product Code
    GIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GIR Reagent, Russel Viper Venom

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GIR), ordered by most recent decision date.

    REAGENT, RUSSEL VIPER VENOM - LA SCREEN

    FDA 510(k)
    FDA Class 1 ·Hematology

    REAGENT, RUSSEL VIPER VENOM - LA CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

    FDA 510(k)
    FDA Class 1 ·Hematology

    STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by Precision Biologic

    K Number Device Name
    K193556 Cryocheck Hex LA
    K193204 Cryocheck Chromogenic Factor VIII
    K032804 CRYOCHECK WEAK LUPUS POSITIVE CONTROL
    K023991 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
    K023990 CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
    K013708 REFERENCE CHECK, CATALOG NUMBER-RCN-10
    K990580 CRYOCHECK LA SURE, MODEL SUR25-10
    K990814 CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
    K990296 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)