FDA 510(k) Application Details - K102568

Device Classification Name	Acid, Uric, Uricase (Colorimetric)   More FDA Info for this Device
510(K) Number	K102568
Device Name	Acid, Uric, Uricase (Colorimetric)
Applicant	ABBOTT LABORATORIES 1921 HURD DRIVE IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	LINDA K MORRIS Other 510(k) Applications for this Contact
Regulation Number	862.1775   More FDA Info for this Regulation Number
Classification Product Code	KNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2010
Decision Date	05/06/2011
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	N
Expedited Review