FDA 510(k) Application Details - K061655

Device Classification Name	Colorimetry, Acetaminophen   More FDA Info for this Device
510(K) Number	K061655
Device Name	Colorimetry, Acetaminophen
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 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	862.3030   More FDA Info for this Regulation Number
Classification Product Code	LDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2006
Decision Date	07/10/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review