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

    B-NEOCEPT

    K Number: K812334 · Decision Sep 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    41
    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
    B-NEOCEPT
    K Number
    K812334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Organon, Inc.
    Date Received
    August 18, 1981
    Decision Date
    September 1, 1981
    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 Organon, Inc.

    K Number Device Name
    K950861 RECONSTITUTION ACCESSOREIS
    K853388 MONOSTICON UNI-DOT
    K842314 DUOCLON COLOR-CEPT
    K841525 OREIA II B-HCG PREGNANCY TEST KIT
    K841602 ACCURATE BETA 30 PREGNANCY TEST KIT
    K840650 B-NEOCEPT 30
    K832801 OREIA II B-HCG, ENZYME INNUNOASSAY
    K831339 NEO-PREGNOSTICON DUOCLON TUBE TEST
    K831109 DUOCLON SLIDE TEST
    K823682 BETA FFIRM TEST
    Search all 41 clearances from Organon, Inc. →