BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENHANCE HTF MEDIUM WITH HEPES

    K Number: K023655 · Decision Dec 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    8
    Review Days
    44

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    Basic Information

    Device Name
    ENHANCE HTF MEDIUM WITH HEPES
    K Number
    K023655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conception Technologies
    Date Received
    October 30, 2002
    Decision Date
    December 13, 2002
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQL Media, Reproductive

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    K011481 10% PVP; 10% PVP IN EBSS SOLUTION
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    K011462 OIL FOR TISSUE CULTURE
    K993140 WATER FOR TISSUE CULTURE, MODELS 1500