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

    AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

    K Number: K031497 · Decision Oct 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    13
    Review Days
    157

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    Basic Information

    Device Name
    AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
    K Number
    K031497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amedica Biotech, Inc.
    Date Received
    May 13, 2003
    Decision Date
    October 17, 2003
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Amedica Biotech, Inc.

    K Number Device Name
    K100108 AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
    K082898 AMEDICA DRUG SCREEN TEST CUP
    K080872 AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
    K063379 AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
    K061556 AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
    K040464 AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
    K023109 AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
    K023104 AMEDICA DRUG SCREEN AMPHETAMINE TEST
    K023101 AMEDICA DRUG SCREEN METHAPHETAMINE TEST
    K023047 AMEDICA DRUG SCREEN OPIATES TEST
    Search all 13 clearances from Amedica Biotech, Inc. →