FDA 510(k) Application Details - DEN110001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN110001
Device Name	RIDASCREEN NOROVIRUS 3RD GENERATION EIA
Applicant	R-Biopharm AG 150 CHERRY LANE RD EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2011
Decision Date	02/23/2011
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