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

    MRI PROLACTIN RIA KIT

    K Number: K810949 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    79
    Applicant Total
    8
    Review Days
    94

    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
    MRI PROLACTIN RIA KIT
    K Number
    K810949
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1625
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Microanalytic Research, Inc.
    Date Received
    April 7, 1981
    Decision Date
    July 10, 1981
    Product Code
    CFT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CFT Radioimmunoassay, Prolactin (Lactogen)

    Similar 510(k) Clearances

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

    PROLACTIN (PRL) HORMONE MICROPLATE ELISA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SEALITE SCIENCES, INC. AQUALITE PROLACTIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELECSYS PROLACTIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DSL ACTIVE PROLACTIN IRMA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Microanalytic Research, Inc.

    K Number Device Name
    K861097 TRYPSIN RIA KIT
    K820741 MR1 LUTROPIN RIA KIT
    K820740 MR1 FOLLITROPIN RIA KIT
    K813516 MRI TOBRAMYCIN RIA KIT
    K812394 MRI GENTAMICIN RIA KIT
    K802754 IMMUNOREACTIVE ESTRIOL RIA KIT
    K801491 MRI HCG-BETA RIA KIT CAT. #MR-10100