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

    CANNU-SKREEN-PRELIMINARY

    K Number: K841831 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    CANNU-SKREEN-PRELIMINARY
    K Number
    K841831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Biochemical Diagnostic, Inc.
    Date Received
    May 3, 1984
    Decision Date
    July 6, 1984
    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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    STATUS CUP ACCUSIGN CUP

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    ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8

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    FDA Class 2 ·Clinical Toxicology

    ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

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    Other Clearances by Biochemical Diagnostic, Inc.

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    K050328 PREGNANCY-SKREEN
    K925586 DETECTABUSE(TM)
    K904181 ANTI-GBM ANTIBODIES QUANTITATIVE KIT