BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THROMBOKINETIC FIBRINOGEN ASSAY

    K Number: K792563 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    37
    Review Days
    30

    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
    THROMBOKINETIC FIBRINOGEN ASSAY
    K Number
    K792563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bio/Data Corp.
    Date Received
    December 12, 1979
    Decision Date
    January 11, 1980
    Product Code
    KQJ
    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
    KQJ System, Fibrinogen Determination

    Similar 510(k) Clearances

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

    HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL FIBRINOGEN-C

    FDA 510(k)
    FDA Class 2 ·Hematology

    DADE THROMBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

    FDA 510(k)
    FDA Class 2 ·Hematology

    FIF TM

    FDA 510(k)
    FDA Class 2 ·Hematology

    N-ASSAY TIA FIBRINOGEN TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Bio/Data Corp.

    K Number Device Name
    K001891 MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
    K943153 MICROSAMPLE COAGULATION ANALYZER
    K893650 PLATELET AGGREGATION PROFILER MODEL PAP-4C
    K881150 KINETIC FIBRINOGEN ASSAY
    K873382 PLATELET EXTRACT REAGENT
    K860751 VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
    K860342 MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
    K854546 MICROSAMPLE COAGULATION ANALYSER MODEL 110P
    K853897 CITREX H
    K853246 CALCIUM CHLORIDE
    Search all 37 clearances from Bio/Data Corp. →