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510(k) K252899

Female Culture Device; Male Culture Device; Transfer Device; Access Device by Zhejiang Kindly Medical Device Co., Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2026
Date Received
September 11, 2025
Clearance Type
Traditional
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

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