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

    MICROLINE SCREEN FOR PHENCYCLIDINE

    K Number: K921651 · Decision Jul 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    93

    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
    MICROLINE SCREEN FOR PHENCYCLIDINE
    K Number
    K921651
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    April 6, 1992
    Decision Date
    July 8, 1992
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

    Similar 510(k) Clearances

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

    Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

    FDA 510(k)
    FDA Unclassified ·Unknown

    SEFRIA PCP Oral Fluid Enzyme Immunoassay

    FDA 510(k)
    FDA Unclassified ·Unknown

    Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

    FDA 510(k)
    FDA Unclassified ·Unknown

    Atellica CH Phencyclidine (Pcp)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Unclassified ·Unknown

    CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Drug Screening Systems, Inc.

    K Number Device Name
    K945829 MICROLINE SCREEN FOR BENZODIAZEPINE
    K935052 MICROLINE SCREEN FOR AMPHETAMINE
    K933480 MICROLINE SCREEN FOR BARBITURATES
    K914915 MICROLINE SCREEN FOR CANNABINOID
    K911652 MIRCOLINE SCREEN FOR COCAINE
    K910525 MICROLINE SCREEN FOR METHAMPHETAMINE
    K905491 MICROLINE SCREEN FOR OPIATES