FDA 510(k) Application Details - K040435

Device Classification Name	Iga, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K040435
Device Name	Iga, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	SHERRI L COENEN Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2004
Decision Date	03/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review