FDA 510(k) Application Details - K033165

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K033165
Device Name	Calibrators, Drug Specific
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	KERWIN KAUFMAN Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2003
Decision Date	10/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review