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510(k) Data Aggregation

    K Number
    K994409
    Device Name
    INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2000-07-10

    (195 days)

    Product Code
    DPK
    Regulation Number
    862.3640
    Why did this record match?
    Product Code :

    DPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instant-View™ Morphine Urine Dip Strip Test is a qualitative immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only. Instant-View Morphine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
    Device Description
    This test is a one-step lateral flow chromatographic immunoassay.
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    K Number
    K994404
    Device Name
    INSTANT-VIEW MORPHINE URINE CASSETTE TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2000-07-05

    (190 days)

    Product Code
    DPK
    Regulation Number
    862.3640
    Why did this record match?
    Product Code :

    DPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instant-View™ Morphine Urine Cassette Test is a qualitative immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only.
    Device Description
    This test is a one-step lateral flow chromatographic immunoassay.
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