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

    ZETA-CORT

    K Number: K821931 · Decision Jul 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    ZETA-CORT
    K Number
    K821931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amf Biological and Diagnostics Co.
    Date Received
    June 29, 1982
    Decision Date
    July 22, 1982
    Product Code
    CGR
    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
    CGR Radioimmunoassay, Cortisol

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    Other Clearances by Amf Biological and Diagnostics Co.

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    K821554 ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
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