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

    AFFINITY PRG

    K Number: K920230 · Decision Feb 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    56
    Applicant Total
    632
    Review Days
    32

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    Basic Information

    Device Name
    AFFINITY PRG
    K Number
    K920230
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1620
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    January 17, 1992
    Decision Date
    February 18, 1992
    Product Code
    JLS
    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
    JLS Radioimmunoassay, Progesterone

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