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

    AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

    K Number: K923314 · Decision Aug 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    48

    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
    AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
    K Number
    K923314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Serex, Inc.
    Date Received
    July 7, 1992
    Decision Date
    August 24, 1992
    Product Code
    JXO
    Advisory Committee
    Clinical Toxicology
    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
    JXO Enzyme Immunoassay, Cocaine

    Similar 510(k) Clearances

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

    Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PSYCHEMEDICS COCAINE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STC DIAGNOSTICS BENZOYLECGONINE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IL TEST(TM) COCAINE

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

    Other Clearances by Serex, Inc.

    K Number Device Name
    K921834 AUTOMATES COMA COCAINE METABOLITE ASSAY
    K901333 BETA-2 MICROGLOBULIN EIA
    K895043 COMA COCAINE METABOLITE ASSAY (EIA)
    K890694 BETA-2 MICROGLOBULIN EIA