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510(k) Data Aggregation

    K Number
    K981800
    Device Name
    SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
    Manufacturer
    EQUAL DIAGNOSTICS, INC.
    Date Cleared
    1998-07-06

    (46 days)

    Product Code
    HIH, DIH, DLI
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUAL DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.
    Device Description
    Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606
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    K Number
    K961179
    Device Name
    SENTINEL LIPASE LIQUID MODEL 17.401B
    Manufacturer
    EQUAL DIAGNOSTICS, INC.
    Date Cleared
    1996-07-19

    (115 days)

    Product Code
    CHI
    Regulation Number
    862.1465
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUAL DIAGNOSTICS, INC.

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

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