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

    GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

    K Number: K003195 · Decision Dec 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
    K Number
    K003195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greer Laboratories, Inc.
    Date Received
    October 12, 2000
    Decision Date
    December 13, 2000
    Product Code
    SCL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SCL Allergen And Vaccine Delivery Needles

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    Other Clearances by Greer Laboratories, Inc.

    K Number Device Name
    K890360 GREER DERMAPIK SYSTEM