FDA 510(k) Application Details - K981059

Device Classification Name	Colorimetry, Acetaminophen   More FDA Info for this Device
510(K) Number	K981059
Device Name	Colorimetry, Acetaminophen
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK CHARLOTTETOWN, P.E.I. C1E1B0 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK, R.T.B.SC 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	03/23/1998
Decision Date	05/12/1998
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