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

    MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)

    K Number: K003847 · Decision May 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    43
    Review Days
    168

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    Basic Information

    Device Name
    MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
    K Number
    K003847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    December 12, 2000
    Decision Date
    May 29, 2001
    Product Code
    LAF
    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
    LAF Gas Chromatography, Methamphetamine

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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
    K060527 INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
    K042227 INSTANT-VIEW TROPONIN I TEST
    K024360 INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
    Search all 43 clearances from Alfa Scientific Designs, Inc. →