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

    INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS

    K Number: K792469 · Decision Jan 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    51

    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
    INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
    K Number
    K792469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Intersci Corp.
    Date Received
    December 3, 1979
    Decision Date
    January 23, 1980
    Product Code
    DOJ
    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
    DOJ Potassium Dichromate, Alcohol

    Similar 510(k) Clearances

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

    ON-SITE ALCOHOL

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