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

    AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C

    K Number: K994093 · Decision Dec 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    47
    Review Days
    13

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    Basic Information

    Device Name
    AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
    K Number
    K994093
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phamatech
    Date Received
    December 3, 1999
    Decision Date
    December 16, 1999
    Product Code
    LCL
    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
    LCL Radioimmunoassay, Phencyclidine

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