FDA 510(k) Application Details - K061238

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K061238
Device Name	Enzymatic, Carbon-Dioxide
Applicant	DADE BEHRING, INC. P.O. BOX 6101 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	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2006
Decision Date	05/25/2006
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