BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)

    K Number: K872303 · Decision Jul 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    22

    Basic Information

    Device Name
    UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)
    K Number
    K872303
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    VANGUARD DIAGNOSTIC SYSTEMS
    Date Received
    June 15, 1987
    Decision Date
    July 7, 1987
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by VANGUARD DIAGNOSTIC SYSTEMS

    K Number Device Name
    K872304 UNASSAYED CONTROL SERUM, NORMAL (BOVINE)