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

    ADI SYPHILIS RPR LIQUID CONTROLS

    K Number: K980638 · Decision Jul 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    137

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    Basic Information

    Device Name
    ADI SYPHILIS RPR LIQUID CONTROLS
    K Number
    K980638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ampcor Diagnostics, Inc.
    Date Received
    February 19, 1998
    Decision Date
    July 6, 1998
    Product Code
    GMP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GMP Antisera, Control For Nontreponemal Tests

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