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

    ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

    K Number: K981801 · Decision Aug 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    72
    Review Days
    96

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    Basic Information

    Device Name
    ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
    K Number
    K981801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    May 21, 1998
    Decision Date
    August 25, 1998
    Product Code
    LFH
    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
    LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs

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