BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    SOURCERER

    K Number: K884091 · Decision Feb 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    1
    Review Days
    127

    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
    SOURCERER
    K Number
    K884091
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    John Caunt Scientific , Ltd.
    Date Received
    September 28, 1988
    Decision Date
    February 2, 1989
    Product Code
    JJJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJJ Counter (Beta, Gamma) For Clinical Use

    Similar 510(k) Clearances

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

    SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ABBOTT VERTEX ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GENESYS 6000 GAMMA COUNTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MATRIX(TM)-96

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOURCERER

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