FDA 510(k) Application Details - K083809

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K083809
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	ABBOTT LABORATORIES 1921 HURD DR. IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	LINDA MORRIS 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	12/22/2008
Decision Date	04/07/2009
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