BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BACTERIURIA DETECT DEVICE, MULTI SAMPLER

    K Number: K843833 · Decision Nov 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    BACTERIURIA DETECT DEVICE, MULTI SAMPLER
    K Number
    K843833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Applied Polytechnology, Inc.
    Date Received
    October 1, 1984
    Decision Date
    November 29, 1984
    Product Code
    JXA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXA Kit, Screening, Urine

    Similar 510(k) Clearances

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

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    URINE SCREENING DEVICE

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    MULTIPLE (IZON DBS & URINE COLLECTION KIT)

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    MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)

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    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Applied Polytechnology, Inc.

    K Number Device Name
    K860483 FILTRA-CHECK-UTI
    K843834 BACTERIURIA DETECT. DEVICE APTEK II
    K843359 URINE TRANSPORT KIT
    K843316 INDOLE SPOT TEST KIT 270-25
    K840257 RAPID IMMUNO-ASSAY SYS
    K834264 REVERSE-FLOW SYSTEM