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510(k) Data Aggregation

    K Number
    K992199
    Device Name
    ACID HEMOGLOBIN KIT
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1999-09-21

    (83 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACID HEMOGLOBIN KIT

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

    The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis.

    The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Acid Hemoglobin Kit." This document does not contain any information about the acceptance criteria, device performance, sample sizes, expert qualifications, or study details that you have requested.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given text.

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