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

    STATUS CUP ACCUSIGN CUP

    K Number: K991751 · Decision Jun 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    72
    Review Days
    25

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    Basic Information

    Device Name
    STATUS CUP ACCUSIGN CUP
    K Number
    K991751
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    May 24, 1999
    Decision Date
    June 18, 1999
    Product Code
    DKE
    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
    DKE Reagents, Test, Tetrahydrocannabinol

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