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510(k) Data Aggregation

    K Number
    K013397
    Device Name
    PACIFIC HEMOSTASIS REFERENCE EMULSION
    Manufacturer
    FISHER DIAGNOSTICS
    Date Cleared
    2002-02-15

    (123 days)

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

    PACIFIC HEMOSTASIS REFERENCE EMULSION

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

    Pacific Hemostasis Reference Emulsion is intended to be used on Instrumentation Laboratories ACL system.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the "Pacific Hemostasis Reference Emulsion" device. This document primarily focuses on regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving device meets acceptance criteria.

    The letter states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device has met regulatory requirements for market approval based on comparison to existing devices, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.

    Therefore, I cannot provide the requested information based on the content of the document.

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