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

    PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO

    K Number: K802343 · Decision Oct 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    6
    Review Days
    14

    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
    PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO
    K Number
    K802343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic, Inc.
    Date Received
    September 26, 1980
    Decision Date
    October 10, 1980
    Product Code
    JHJ
    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
    JHJ Agglutination Method, Human Chorionic Gonadotropin

    Similar 510(k) Clearances

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

    PREGNACOL PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SAS(TM) DIRECT MONOCLONAL HCG

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCUTEX BETA-HCG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SAS(TM) MONOCLONAL HCG-SLIDE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIRECT PREGNANCY TEST

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

    Other Clearances by Intl. Diagnostic, Inc.

    K Number Device Name
    K841853 PREG-BETA ONE HOUR TUBE TEST
    K840833 PREG BETA BLUS SLIDE
    K834584 NABI CRP-Q.S. TEST
    K840005 NABI RF-Q.S. TEST
    K780321 PREGNANCY TEST KIT, OVER-THE-COUNTER