K-number	K201269
Device name	Accula Strep A Test
Applicant	Mesa Biotech, Inc.
Product code	PGX
Device class	Class II
Decision date	Nov 9, 2020
Decision	Substantially Equivalent
Regulation	866.2680

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Source

View the full FDA submission: accessdata.fda.gov

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Accula Strep A Test

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