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510(k) Data Aggregation

    K Number
    K991396
    Device Name
    WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
    Manufacturer
    SAGE BIOPHARMA
    Date Cleared
    2000-02-15

    (300 days)

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

    WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L

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

    Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures.

    Device Description

    Water for Tissue Culture 500mL

    AI/ML Overview

    This document is a letter from the FDA regarding a 510(k) premarket notification for "Water for Tissue Culture" by Advanced Reproductive Technologies, Inc. It details the FDA's determination of substantial equivalence to a legally marketed predicate device.

    There is no information in the provided text that describes acceptance criteria, device performance, sampling methods, expert qualifications, ground truth establishment, or any study details as requested in your prompt.

    The document primarily focuses on regulatory approval, classification, and general controls applicable to the device. It states the intended "Indications For Use" for the device: "Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures." However, it does not include any performance metrics or study results.

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