BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &

    K Number: K851738 · Decision May 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    366
    Applicant Total
    6
    Review Days
    20

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    Basic Information

    Device Name
    MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
    K Number
    K851738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma
    Date Received
    April 25, 1985
    Decision Date
    May 15, 1985
    Product Code
    KIT
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIT Media And Components, Synthetic Cell And Tissue Culture

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    Other Clearances by Sigma

    K Number Device Name
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    K851737 MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
    K830038 SIGMA 7000-6000 INFUSION PUMPS
    K820038 SIGMA 7000