FDA 510(k) Application Details - K100853

Device Classification Name	Albumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K100853
Device Name	Albumin, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	ANGELO PEREIRA Other 510(k) Applications for this Contact
Regulation Number	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2010
Decision Date	09/09/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review