K-number	K220016
Device name	Viramed Borrela All-In-One ViraChip Test Kit
Applicant	Viramed Biotech AG
Product code	LSR
Device class	Class II
Decision date	Aug 19, 2022
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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Viramed Borrela All-In-One ViraChip Test Kit

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