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510(k) Data Aggregation

    K Number
    K974053
    Device Name
    AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1997-12-08

    (42 days)

    Product Code
    JFJ
    Regulation Number
    862.1070
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k974037
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of a-amylase in serum. For IN VITRO diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

    The document is an FDA 510(k) clearance letter for the "a-Amylase-SL Assay," indicating that the device is substantially equivalent to a predicate device and can be marketed. It states the indications for use and general regulatory information but does not include any performance study details or acceptance criteria.

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