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510(k) Data Aggregation

    K Number
    K041435
    Device Name
    THE STRIPPER PGD
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2004-09-29

    (124 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE STRIPPER PGD

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

    The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.

    Device Description

    Stripper PGD® Micropipette and associated tip

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Stripper PGD® Micropipette and associated tip." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the information requested in the prompt regarding acceptance criteria, device performance, study details, or ground truth.

    The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance or the studies that would demonstrate compliance with acceptance criteria.

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

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