FDA 510(k) Application Details - K102699

Device Classification Name	Enzyme Immunoassay, Gentamicin   More FDA Info for this Device
510(K) Number	K102699
Device Name	Enzyme Immunoassay, Gentamicin
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6 AP6C-2 ABBOTT PARK, IL 60064-6092 US Other 510(k) Applications for this Company
Contact	JUDITH WALLACH Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	LCD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2010
Decision Date	04/01/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review