FDA 510(k) Application Details - DEN070006

Device Classification Name	Plasmodium Spp. Detection Reagents   More FDA Info for this Device
510(K) Number	DEN070006
Device Name	Plasmodium Spp. Detection Reagents
Applicant	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	Anne Jepson Other 510(k) Applications for this Contact
Regulation Number	866.3402   More FDA Info for this Regulation Number
Classification Product Code	OAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2007
Decision Date	06/13/2007
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