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

    SPERM WASH MEDIUM, CAT# 2003/2005

    K Number: K000989 · Decision Jun 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    10
    Review Days
    72

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    Basic Information

    Device Name
    SPERM WASH MEDIUM, CAT# 2003/2005
    K Number
    K000989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invitrocare, Inc.
    Date Received
    March 28, 2000
    Decision Date
    June 8, 2000
    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 Invitrocare, Inc.

    K Number Device Name
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    K003751 HYALURONIDASE REAGENT, MODEL CAT#2212
    K001967 PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
    K001113 IVC THREE BLASTOCYST MEDIUM, CAT # 2007
    K000937 IVC TWO MEDIUM
    K993484 Q-HTF, CAT# 2001
    K000938 IVC ONE MEDIUM
    K000939 HTF-HEPES
    K000940 HUMAN SERUM ALBUMIN (HSA)