FDA 510(k) Application Details - K080183

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K080183
Device Name	Drug Mixture Control Materials
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BX 50416 INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	DIMITRIS DEMIRTZOGLOU Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2008
Decision Date	03/25/2008
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