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    K Number
    K010079
    Device Name
    INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2001-05-29

    (139 days)

    Product Code
    DOE
    Regulation Number
    862.3640
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K010080
    Device Name
    INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2001-05-29

    (139 days)

    Product Code
    DOE
    Regulation Number
    862.3640
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K011011
    Device Name
    LIVESURE MORPHINE SCREEN TEST
    Manufacturer
    PAN PROBE BIOTECH, INC.
    Date Cleared
    2001-04-13

    (9 days)

    Product Code
    DOE
    Regulation Number
    862.3640
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K002418
    Device Name
    BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
    Manufacturer
    BRANAN MEDICAL CORPORATION
    Date Cleared
    2000-11-22

    (106 days)

    Product Code
    DOE
    Regulation Number
    862.3640
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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