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

    IMMPULSE CORTISOL ASSAY REAGENTS

    K Number: K842554 · Decision Aug 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    41

    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
    IMMPULSE CORTISOL ASSAY REAGENTS
    K Number
    K842554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Aktis Corp.
    Date Received
    July 2, 1984
    Decision Date
    August 12, 1984
    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

    Similar 510(k) Clearances

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

    Access Cortisol; DxC 500i Clinical Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access Cortisol

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IDS Cortisol

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE/IMMULITE® 1000 Cortisol

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE® 2000 Cortisol

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CORTISOL ELISA

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

    Other Clearances by Aktis Corp.

    K Number Device Name
    K842571 IMMPULSE DIGOXIN ASSAY REAGENTS