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

    Arctic Sperm Cryopreservation Medium

    K Number: K171224 · Decision Aug 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    40
    Review Days
    127

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    Basic Information

    Device Name
    Arctic Sperm Cryopreservation Medium
    K Number
    K171224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Irvine Scientific Sales Co., Inc.
    Date Received
    April 26, 2017
    Decision Date
    August 31, 2017
    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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    Other Clearances by Irvine Scientific Sales Co., Inc.

    K Number Device Name
    K170681 Continuous Single Culture -NX (CSCM-NX)
    K170602 Continuous Single Culture-NX Complete (CSCM-NXC)
    K121572 CONTINUOUS SINGLE CULTURE COMPLETE
    K121128 MULTIPURPOSE HANDLING MEDIUM
    K093273 VIT KIT - FREEZE AND THAW
    K072609 SINGLE STEP MEDIUM
    K072608 LYOPHILIZED MULTIBLAST MEDIUM KIT
    K072607 LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
    K061549 AMNIOSTAT-FLM-PG
    K061679 WALLACE ARTIFICIAL INSEMINATION CATHETER
    Search all 40 clearances from Irvine Scientific Sales Co., Inc. →