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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
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Sentinel Cholinesterase Liquid" device. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.

    The document primarily focuses on:

    • Granting substantial equivalence to a predicate device.
    • Indications for use ("For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.").
    • Regulatory classifications and general controls.

    Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth. These details would typically be found in the 510(k) submission itself or in a separate study report, none of which are included in the provided text.

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