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

    NORDICLAB ESTRADIOL RIA TEST

    K Number: K800920 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    49
    Applicant Total
    8
    Review Days
    23

    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
    NORDICLAB ESTRADIOL RIA TEST
    K Number
    K800920
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nordiclab Intl.
    Date Received
    April 21, 1980
    Decision Date
    May 14, 1980
    Product Code
    CHP
    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
    CHP Radioimmunoassay, Estradiol

    Similar 510(k) Clearances

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

    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    17 B-ESTRADIOL (ELISA)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACS ESTADIOL-6 II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)

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

    Other Clearances by Nordiclab Intl.

    K Number Device Name
    K801988 NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
    K801989 NORDICLAB FERRITIN IRMA TEST
    K800922 NORDICLAB PROGESTERONE RIA TEST
    K800921 NORDICLAB TESTOSTERONE RIA TEST
    K792189 NORDICLAB TOTAL ESTRIOL RIA TEST
    K782157 IRMA TEST, NORDICLAB FERRITIN
    K782099 RIA TEST, NORDICALB HPL