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

    Steripath Micro Blood Collection System

    K Number: K222299 · Decision Nov 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    Steripath Micro Blood Collection System
    K Number
    K222299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magnolia Medical Technologies
    Date Received
    August 1, 2022
    Decision Date
    November 30, 2022
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Magnolia Medical Technologies

    K Number Device Name
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