FDA 510(k) Application Details - K051087

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K051087
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant	DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	LORRAINE H PIESTRAK Other 510(k) Applications for this Contact
Regulation Number	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2005
Decision Date	07/11/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review