FDA 510(k) Application Details - K121942

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K121942
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	ARGENE SA PARC TECHNOLOGIQUE DELTA SUD VARILHES 09120 FR Other 510(k) Applications for this Company
Contact	ERIC BRISSON Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2012
Decision Date	02/08/2013
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