FDA 510(k) Application Details - K071239

Device Classification Name	Turbidimetric, Total Protein   More FDA Info for this Device
510(K) Number	K071239
Device Name	Turbidimetric, Total Protein
Applicant	Roche Diagnostics 9155 HAGUE RD. PO BOX 50416 INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	CORINA HARPER Other 510(k) Applications for this Contact
Regulation Number	862.1635   More FDA Info for this Regulation Number
Classification Product Code	JGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2007
Decision Date	09/14/2007
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
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