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510(k) Data Aggregation

    K Number
    K961436
    Device Name
    ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1996-06-21

    (67 days)

    Product Code
    DLB
    Regulation Number
    862.3580
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K955448
    Device Name
    EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-02-23

    (86 days)

    Product Code
    DLB
    Regulation Number
    862.3580
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DLB

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

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    K Number
    K955814
    Device Name
    CEDIA DAU LSD ASSAY
    Manufacturer
    MICROGENICS CORP.
    Date Cleared
    1996-02-09

    (45 days)

    Product Code
    DLB
    Regulation Number
    862.3580
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DLB

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

    Ask a specific question about this device

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