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

    BIOGLAS MICROCARRIER BEAD

    K Number: K852506 · Decision Jul 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    BIOGLAS MICROCARRIER BEAD
    K Number
    K852506
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Solohill Engineering, Inc.
    Date Received
    June 12, 1985
    Decision Date
    July 12, 1985
    Product Code
    KJB
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJB Apparatus, Roller

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