FDA 510(k) Application Details - K081193

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K081193
Device Name	Diazo Colorimetry, Bilirubin
Applicant	Roche Diagnostics 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	JENNIFER TRIBBETT Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2008
Decision Date	01/16/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review