FDA 510(k) Application Details - K042330

Device Classification Name	Colorimetry, Acetaminophen   More FDA Info for this Device
510(K) Number	K042330
Device Name	Colorimetry, Acetaminophen
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. WEST ROYALTY INDUSTRIAL PARK CHARLOTTETOWN, PRINCE EDWARD C1E 2A6 CA Other 510(k) Applications for this Company
Contact	NANCY OLSCAMP 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	08/27/2004
Decision Date	01/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review