FDA 510(k) Application Details - K051757

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K051757
Device Name	Azo Dye, Calcium
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN C1E 2A6 CA Other 510(k) Applications for this Company
Contact	PENNY WHITE Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2005
Decision Date	11/10/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review