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510(k) Data Aggregation

    K Number
    K973350
    Device Name
    BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-02-09

    (157 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST

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

    THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE (17-OHP) TEST IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF ιτα HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE AS AN ALD IN SCREENING NEWBORNS FOR CONGENITAL, ADRENAL HYPERPLASIA.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing authorization letter from the FDA for a medical device called "Microplate 17-Hydroxyprogesterone Test". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this letter does not contain any information about the acceptance criteria, study details, or performance data of the device. It is purely a regulatory approval document.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as that information is not present in the provided text.

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