FDA 510(k) Application Details - K081938

Device Classification Name	Colorimetry, Acetaminophen   More FDA Info for this Device
510(K) Number	K081938
Device Name	Colorimetry, Acetaminophen
Applicant	GENZYME DIAGNOSTICS P.E.I. INC. 700 WATTS AVENUE CHARLOTTETOWN, PRIN ED ISLAND C1E 2B9 CA Other 510(k) Applications for this Company
Contact	PENNY J WHITE 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	07/08/2008
Decision Date	05/01/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review