FDA 510(k) Application Details - K973931

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K973931
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
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	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1997
Decision Date	11/24/1997
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