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510(k) Data Aggregation

    K Number
    K992517
    Device Name
    BIOCHECK FERRITIN ELISA MODEL BC-1025
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-09-24

    (58 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCHECK FERRITIN ELISA MODEL BC-1025

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

    The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

    Device Description

    BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, etc.), or expert involvement. The document is a 510(k) clearance letter from the FDA for a medical device called "BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit," approving its marketing. It primarily focuses on the regulatory aspects and indications for use, without detailing the performance study methodology or results.

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