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510(k) Data Aggregation

    K Number
    K020710
    Device Name
    BIOTEST HEMOGLOBIN MEASURING SYSTEM
    Manufacturer
    BIOTEST MEDIZINTECHNIK GMBH
    Date Cleared
    2002-08-14

    (162 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Type
    Abbreviated
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but there is no information about acceptance criteria or a study that proves the device meets the acceptance criteria in the provided text. The document is an FDA 510(k) substantial equivalence letter for the Bio.Track LLC Biotest Hemoglobin Measuring System, which primarily confirms that the device can be marketed. It does not contain details regarding performance studies, sample sizes, ground truth establishment, or expert qualifications.

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