FDA 510(k) Application Details - K955498

Device Classification Name	Colorimetry, Cholinesterase   More FDA Info for this Device
510(K) Number	K955498
Device Name	Colorimetry, Cholinesterase
Applicant	DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK Other 510(k) Applications for this Contact
Regulation Number	862.3240   More FDA Info for this Regulation Number
Classification Product Code	DIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1995
Decision Date	01/24/1996
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