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510(k) Data Aggregation

    K Number
    K973055
    Device Name
    WAKO CH50 LINEARITY SET
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    1997-09-25

    (41 days)

    Product Code
    JIW
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WAKO CH50 LINEARITY SET

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

    The CH50 Linearity Set is to be used with WAKO Autokit CH50 test for the estimation of the linearity limits of the reagent/instrument system for the CH50 analyte.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a device called "Wako CH50 Linearity Set." This document does not contain information about acceptance criteria or performance studies of the device against such criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study as would be described for a new, novel device.

    Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) from this document. The document primarily confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed devices.

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