FDA 510(k) Application Details - K972337

Device Classification Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K972337
Device Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
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	862.1645   More FDA Info for this Regulation Number
Classification Product Code	JIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/1997
Decision Date	08/08/1997
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