FDA 510(k) Application Details - K043095

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K043095
Device Name	Calibrator, Secondary
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	KAY A TAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2004
Decision Date	11/23/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review