FDA 510(k) Application Details - K961586

Device Classification Name	Acid, Uric, Uricase (Colorimetric)   More FDA Info for this Device
510(K) Number	K961586
Device Name	Acid, Uric, Uricase (Colorimetric)
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	862.1775   More FDA Info for this Regulation Number
Classification Product Code	KNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1996
Decision Date	07/23/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review