LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991762
    Device Name
    ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-09-02

    (101 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

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

    This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, in serum. Measurments of Alkaline quantitative determination of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, Phosphatase parathyroid, and intestinal diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a device called "Alkaline Phosphatase." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document simply approves the device for marketing based on substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1