Disposable Urine Collection Tube

Culture Media, Non-propagating Transport

Zhejiang Gongdong Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Technology Co., Ltd. with the FDA for Disposable Urine Collection Tube.

Pre-market Notification Details

Device IDK220739
510k NumberK220739
Device Name:Disposable Urine Collection Tube
ClassificationCulture Media, Non-propagating Transport
Applicant Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan Taizhou,  CN 318020
ContactHandson Wei
CorrespondentEvan Hu
Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai,  CN 201114
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-14
Decision Date2022-11-17

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.