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

    STC DIAGNOSTICS BENZOYLECGONINE EIA

    K Number: K915785 · Decision Mar 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    28
    Review Days
    78

    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
    STC DIAGNOSTICS BENZOYLECGONINE EIA
    K Number
    K915785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare Technologies Corp,Inc.
    Date Received
    December 24, 1991
    Decision Date
    March 11, 1992
    Product Code
    JXO
    Advisory Committee
    Clinical Toxicology
    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
    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

    AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE 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 Solarcare Technologies Corp,Inc.

    K Number Device Name
    K954326 STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
    K954156 STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
    K955905 STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
    K954158 STC DIAGNOSTICS AUTO-LYTE PH ASSAY
    K940048 STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
    K954073 STC DIAGNOSTICS LSD MICRO-PLATE EIA
    K954266 STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
    K935573 AMPHETAMINES MICRO-PLATE EIA
    K935565 OPIATES MICRO-PLATE ASSAY
    K950308 STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
    Search all 28 clearances from Solarcare Technologies Corp,Inc. →