FDA 510(k) Application Details - K141173

Device Classification Name	More FDA Info for this Device
510(K) Number	K141173
Device Name	AMPLIVUE GAS ASSAY
Applicant	QUIDEL CORPORATION 2005 E State St Suite 100 ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	Ronald H Lollar 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	05/06/2014
Decision Date	07/24/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review