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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K252899
Device Name Female Culture Device; Male Culture Device; Transfer Device; Access Device
Applicant
Zhejiang Kindly Medical Device Co., Ltd.
No 758, 5th Binhai Rd., Binhai Industrial Park, Longwan
Wenzhou, Zhejiang
Wenzhou,  CN 325000
Applicant Contact Qian Zhang
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
377 Tianzhu Rd., Jiading
Shanghai,  CN 201801
Correspondent Contact Evan Hu
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/11/2025
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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