FDA 510(k) Application Details - DEN030002

Device Classification Name	Assay, Endotoxin Activity, Chemiluminescent   More FDA Info for this Device
510(K) Number	DEN030002
Device Name	Assay, Endotoxin Activity, Chemiluminescent
Applicant	SPECTRAL DIAGNOSTICS, INC. 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	TOM TSAKERIS Other 510(k) Applications for this Contact
Regulation Number	866.3210   More FDA Info for this Regulation Number
Classification Product Code	NGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2003
Decision Date	06/16/2003
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