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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K220739
Device Name Disposable Urine Collection Tube
Applicant
Zhejiang Gongdong Medical Technology Co., Ltd.
#10 Beiyuan Ave., Huangyan
Taizhou,  CN 318020
Applicant Contact Handson Wei
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
1399 Jiangyue Rd., Minhang
Shanghai,  CN 201114
Correspondent Contact Evan Hu
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received03/14/2022
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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