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

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

    K Number: K190485 · Decision Jul 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    11
    Review Days
    131

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    Basic Information

    Device Name
    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
    K Number
    K190485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories, Inc.
    Date Received
    February 27, 2019
    Decision Date
    July 8, 2019
    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 Kawasumi Laboratories, Inc.

    K Number Device Name
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    K100720 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
    K102994 K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
    K073257 KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR
    K061197 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
    K060580 K-SHIELD PORT ACCESS INFUSION SET
    K023917 WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
    K022110 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
    Search all 11 clearances from Kawasumi Laboratories, Inc. →