BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

    K Number: K223810 · Decision Feb 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
    K Number
    K223810
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sb-Kawasumi Laboratories, Inc.
    Date Received
    December 20, 2022
    Decision Date
    February 24, 2023
    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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