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

    INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

    K Number: K060527 · Decision Jul 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    43
    Review Days
    147

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    Basic Information

    Device Name
    INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
    K Number
    K060527
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    February 28, 2006
    Decision Date
    July 25, 2006
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Alfa Scientific Designs, Inc.

    K Number Device Name
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    K173212 Instant-view-PLUS immunochemical Fecal Occult Blood Test
    K152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
    K131645 INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
    K100051 INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
    K070660 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
    K063545 MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
    K042227 INSTANT-VIEW TROPONIN I TEST
    K024360 INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
    K022693 INSTANT-VIEW TCA URINE TEST
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