FDA 510(k) Application Details - K072638

Device Classification Name	Turbidimetric, Total Protein   More FDA Info for this Device
510(K) Number	K072638
Device Name	Turbidimetric, Total Protein
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	KERWIN L KAUFMAN 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	09/18/2007
Decision Date	10/19/2007
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
Expedited Review