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

    THROMBO SCREEN QUANTITATIVE HEPARIN ASSA

    K Number: K770722 · Decision Jul 11, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    83

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    Basic Information

    Device Name
    THROMBO SCREEN QUANTITATIVE HEPARIN ASSA
    K Number
    K770722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bay Area Hema. Onco. Clinic. & Res. L
    Date Received
    April 19, 1977
    Decision Date
    July 11, 1977
    Product Code
    JBR
    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
    JBR Test, Heparin Neutralization

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    Other Clearances by Bay Area Hema. Onco. Clinic. & Res. L

    K Number Device Name
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    K770394 THROMBO-SCREEN AT-111 KIT
    K770395 THROMBO-CETIN (RISTOCETIN)