FDA 510(k) Application Details - K051191

Device Classification Name	Albumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K051191
Device Name	Albumin, Antigen, Antiserum, Control
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	PENNY WHITE Other 510(k) Applications for this Contact
Regulation Number	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2005
Decision Date	07/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review