BioTeke Sterile Disposable Virus Sampling Kit

Culture Media, Non-propagating Transport

BioTeke Corporation (WuXi) Co., Ltd

The following data is part of a premarket notification filed by Bioteke Corporation (wuxi) Co., Ltd with the FDA for Bioteke Sterile Disposable Virus Sampling Kit.

Pre-market Notification Details

Device IDK211707
510k NumberK211707
Device Name:BioTeke Sterile Disposable Virus Sampling Kit
ClassificationCulture Media, Non-propagating Transport
Applicant BioTeke Corporation (WuXi) Co., Ltd 4th Floor, D5, No. 1719, Huishan Avenue Wuxi City,  CN 21474
ContactZhitu Zhou
CorrespondentKenneth Kleinhenz
QSR Consulting 10807 Dakota Ranch Rd. Santee,  CA  92071
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2022-05-04

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