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

    QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM

    K Number: K972969 · Decision Sep 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    42

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    Basic Information

    Device Name
    QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
    K Number
    K972969
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6150
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Medical Technologies, Inc.
    Date Received
    August 11, 1997
    Decision Date
    September 22, 1997
    Product Code
    GIO
    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
    GIO Tube, Collection, Capillary Blood

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