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

    RSL (125 L) PROGESTERONE KIT

    K Number: K800126 · Decision Feb 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    56
    Applicant Total
    15
    Review Days
    26

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    Basic Information

    Device Name
    RSL (125 L) PROGESTERONE KIT
    K Number
    K800126
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1620
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioassay Systems Laboratories, Inc.
    Date Received
    January 18, 1980
    Decision Date
    February 13, 1980
    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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    Other Clearances by Radioassay Systems Laboratories, Inc.

    K Number Device Name
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    K831855 HATCH KIT
    K802195 DEHYDROEPIANDROSTERONE SULFATE KIT RIA
    K791999 (125I) TESTOSTERONE KIT
    K791651 TOTAL ESTROGENS KIT BY RIA
    K791728 RSL'S ASSAY PROCEDURE QUANTITATION
    K791740 SERUM 11-DESOXYCORTISOL I AS TRACER
    K791835 CORALENT COAT 125I CORTISOL RADIOIMM.
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