FDA 510(k) Application Details - K173653

Device Classification Name	More FDA Info for this Device
510(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. 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Danielle A. Briggeman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2017
Decision Date	05/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review