FDA 510(k) Application Details - K040631

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K040631
Device Name	Diazo Colorimetry, Bilirubin
Applicant	CLINICAL DATA, INC. 1075 WEST LAMBERT ROAD BREA, CA 92821-2944 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2004
Decision Date	03/18/2004
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