FDA 510(k) Application Details - K071280

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K071280
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 BREA, CA 92822-8000 US Other 510(k) Applications for this Company
Contact	TARA M VIVIANI Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2007
Decision Date	06/01/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review