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510(k) Data Aggregation

    K Number
    K973898

    Validate with FDA (Live)

    Device Name
    PROGESTERONE ELISA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Progesterone ELISA Test Kit. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Thus, I cannot answer questions 1-9 based on the provided text.

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