FDA 510(k) Application Details - K033983

Device Classification Name	Photometric Method, Iron (Non-Heme)   More FDA Info for this Device
510(K) Number	K033983
Device Name	Photometric Method, Iron (Non-Heme)
Applicant	CLINICAL DATA, INC. 1075 W. LAMBERT ROAD SUITE D BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING Other 510(k) Applications for this Contact
Regulation Number	862.1410   More FDA Info for this Regulation Number
Classification Product Code	JIY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2003
Decision Date	05/21/2004
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	Y
Expedited Review