FDA 510(k) Application Details - DEN140005

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140005
Device Name	LYRA DIRECT STREP ASSAY
Applicant	QUIDEL CORPORATION 2005 EAST 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	03/25/2014
Decision Date	04/16/2014
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review