Name: Predicase
Price: 199 USD

K-number	K173653
Device name	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Applicant	Alere Scarborough, Inc.
Product code	PGX
Device class	Class II
Decision date	May 2, 2018
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 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

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