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510(k) Data Aggregation

    K Number
    K032155
    Device Name
    G-THAWKIT BLAST
    Manufacturer
    VITROLIFE AB
    Date Cleared
    2004-05-07

    (298 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K000309
    Why did this record match?
    Device Name :

    G-THAWKIT BLAST

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

    Intended Use: Medium for In Vitro Fertilization Procedures
    Indications for Use: Media for thawing of blastocyst stage embryos

    Device Description

    MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.

    AI/ML Overview

    This document is a 510(k) premarket notification for the G-ThawKit Blast™ Assisted Reproductive Media. It does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document primarily establishes substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information from the provided text. To answer your query, a document containing the detailed results of performance studies and acceptance criteria for the G-ThawKit Blast™ would be needed.

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