LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964297
    Device Name
    N-ASSAY TIA C4 TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (258 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    N-ASSAY TIA C4 TEST KIT

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

    The N-4ssay TIA Test Kit is intended to be used for the quantitative determination of human (4 (4th complement component) in human serum by immunoturbidimetric assay. Cl4 aids in the diagnosing of immunological disorders, especially the entile with complement deficiency disorders, with complement deficiency disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "N-Assay TIA C4 Test Kit." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment or expert involvement.

    The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed. It also provides regulatory information and contact details.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1