K-number	K141757
Device name	ALERE I STREP A
Applicant	Alere Scarborough, Inc.
Product code	PGX
Device class	Class II
Decision date	Mar 31, 2015
Decision	Substantially Equivalent
Regulation	866.2680

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Source

View the full FDA submission: accessdata.fda.gov

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ALERE I STREP A

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