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

    COAG-1 APTT TEST CARD

    K Number: K891015 · Decision May 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    8
    Review Days
    83

    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
    COAG-1 APTT TEST CARD
    K Number
    K891015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Diagnostic Services
    Date Received
    February 28, 1989
    Decision Date
    May 22, 1989
    Product Code
    GFO
    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
    GFO Activated Partial Thromboplastin

    Similar 510(k) Clearances

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

    HemosIL Silica Clotting Time

    FDA 510(k)
    FDA Class 2 ·Hematology

    Cryocheck Hex LA

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL Silica Clotting Time

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA-CEPHASCREEN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL SYNTHASIL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL SILICA CLOTTING TIME

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

    Other Clearances by Cardiovascular Diagnostic Services

    K Number Device Name
    K955843 TAS PTONE
    K933092 TAS ANALYZER
    K904325 COAG-1 PT-NC TEST CARD
    K903019 MODIFIED COAG-1 PT TEST CARD
    K882444 COAG-I ANALYZER, ALPHA MODEL
    K882456 COAG-I PT TEST CARD
    K812304 DORROS-SPRING PRESSURIZER