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

    INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

    K Number: K994405 · Decision Jun 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    43
    Review Days
    157

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    Basic Information

    Device Name
    INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
    K Number
    K994405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    December 28, 1999
    Decision Date
    June 2, 2000
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DKE), ordered by most recent decision date.

    VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC

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    STATUS STIK, ACCUSIGN STIK

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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

    FDA 510(k)
    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

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROFILE-II MODEL 600582

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
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    Other Clearances by Alfa Scientific Designs, Inc.

    K Number Device Name
    K173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
    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. →