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

    ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

    K Number: K980249 · Decision Mar 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    20
    Applicant Total
    72
    Review Days
    49

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    Basic Information

    Device Name
    ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
    K Number
    K980249
    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
    January 23, 1998
    Decision Date
    March 13, 1998
    Product Code
    LFG
    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
    LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

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