K-number	K211707
Device name	BioTeke Sterile Disposable Virus Sampling Kit
Applicant	Bioteke Corporation (Wuxi) Co., Ltd.
Product code	JSM
Device class	Class I
Decision date	May 4, 2022
Decision	Substantially Equivalent
Regulation	866.2390

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Source

View the full FDA submission: accessdata.fda.gov

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BioTeke Sterile Disposable Virus Sampling Kit

Everything you need for a 510(k) submission. Nothing you don't.