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

    SERUM 11-DESOXYCORTISOL I AS TRACER

    K Number: K791740 · Decision Sep 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    15
    Review Days
    17

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    Basic Information

    Device Name
    SERUM 11-DESOXYCORTISOL I AS TRACER
    K Number
    K791740
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1185
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioassay Systems Laboratories, Inc.
    Date Received
    September 10, 1979
    Decision Date
    September 27, 1979
    Product Code
    JKB
    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
    JKB Radioimmunoassay, Compound S (11-Deoxycortisol)

    Other Clearances by Radioassay Systems Laboratories, Inc.

    K Number Device Name
    K862204 RSL (125I) ALDOSTERONE KIT
    K842960 ANDROSTENEDIONE BY RIA
    K840886 HYDROXYPROGESTERONE BY RIA 17A
    K831855 HATCH KIT
    K802195 DEHYDROEPIANDROSTERONE SULFATE KIT RIA
    K800126 RSL (125 L) PROGESTERONE KIT
    K791999 (125I) TESTOSTERONE KIT
    K791651 TOTAL ESTROGENS KIT BY RIA
    K791728 RSL'S ASSAY PROCEDURE QUANTITATION
    K791835 CORALENT COAT 125I CORTISOL RADIOIMM.
    Search all 15 clearances from Radioassay Systems Laboratories, Inc. →