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510(k) K223810

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) by Sb-Kawasumi Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2023
Date Received
December 20, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sb-Kawasumi Laboratories, Inc.

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  • K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (June 1, 2023)
  • K220799 — K-SHIELD Zen (August 29, 2022)

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