K-number	K183366
Device name	GenePOC Strep A
Applicant	Genepoc, Inc.
Product code	PGX
Device class	Class II
Decision date	Mar 6, 2019
Decision	Substantially Equivalent
Regulation	866.2680

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Source

View the full FDA submission: accessdata.fda.gov

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GenePOC Strep A

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