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510(k) Data Aggregation

    K Number
    K990978
    Device Name
    ALBUMIN BCG, MODEL AL 103-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (63 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALBUMIN BCG, MODEL AL 103-01

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

    THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to A.P. Total Care, Inc. regarding their "Albumin BCG" reagent. This document is a regulatory approval letter and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device.

    The letter confirms the device is substantially equivalent to legally marketed predicate devices and is intended for in vitro diagnostic use in the quantitative determination of albumin in serum or plasma. It mentions general regulatory compliance but does not include any specific performance data, study designs, sample sizes, or expert qualifications.

    Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, would be required.

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