LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K963147
    Device Name
    ELECSYS CALCHECK TSH
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-08-23

    (10 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K924862
    Why did this record match?
    Device Name :

    ELECSYS CALCHECK TSH

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

    Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

    Device Description

    The Elecsys CalCheck TSH is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) summary for a calibration verification material (Elecsys CalCheck TSH), focusing on its intended use and establishing substantial equivalence to a predicate device.

    Therefore, I cannot populate the requested tables and answer the questions based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1