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

    RSL (125I) ALDOSTERONE KIT

    K Number: K862204 · Decision Sep 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    15
    Review Days
    107

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RSL (125I) ALDOSTERONE KIT
    K Number
    K862204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1045
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioassay Systems Laboratories, Inc.
    Date Received
    June 10, 1986
    Decision Date
    September 25, 1986
    Product Code
    CJM
    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
    CJM Radioimmunoassay, Aldosterone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CJM), ordered by most recent decision date.

    IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NICHOLS ADVANTAGE ALDOSTERONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NICHOLS ADVANTAGE ALDOSTERONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DSL ACTIVE ALDOSTERONE RIA (DSL 8600)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DSL ACTIVE ALDOSTERONE (DSL 8600)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Radioassay Systems Laboratories, Inc.

    K Number Device Name
    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
    K791740 SERUM 11-DESOXYCORTISOL I AS TRACER
    K791835 CORALENT COAT 125I CORTISOL RADIOIMM.
    Search all 15 clearances from Radioassay Systems Laboratories, Inc. →