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

    INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

    K Number: K984075 · Decision Feb 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    43
    Review Days
    92

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    Basic Information

    Device Name
    INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
    K Number
    K984075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    November 16, 1998
    Decision Date
    February 16, 1999
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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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. →