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510(k) Data Aggregation

    K Number
    K973999
    Device Name
    CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-03-11

    (141 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

    Device Description

    Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Creatine Kinase-SL Assay" and does not contain the detailed information required to describe acceptance criteria and associated study results. The letter confirms substantial equivalence to a predicate device but does not specify performance metrics, study designs, sample sizes, or ground truth methodologies.

    Therefore, I cannot provide the requested information based on the given input.

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