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

    SIMPLATE

    K Number: K761250 · Decision Mar 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    39
    Review Days
    78

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    Basic Information

    Device Name
    SIMPLATE
    K Number
    K761250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    December 13, 1976
    Decision Date
    March 1, 1977
    Product Code
    JCA
    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
    JCA Device, Bleeding Time

    Similar 510(k) Clearances

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

    SIMPLATE PEDIATRIC

    FDA 510(k)
    FDA Class 2 ·Hematology

    SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Hematology

    Q.I.C. BLEEDING TIME DEVICE

    FDA 510(k)
    FDA Class 2 ·Hematology

    SURGICUTT - BLEEDING TIME DEVICE

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLEEDING TIME DEVICE DISPOSABLE

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTOLET

    FDA 510(k)
    FDA Class 2 ·Hematology
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    K864993 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
    K863877 BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
    K842307 GENERAL DIAG. CEFONICID 30MCG ANTIMIC
    K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY
    K833709 CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
    K832653 CEFUROXIME 30MCG. SUSCEP DISK
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