FDA 510(k) Application Details - K100101

Device Classification Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase   More FDA Info for this Device
510(K) Number	K100101
Device Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Applicant	PERKINELMER, INC. 8275 CARLOWAY ROAD INDIANAPOLIS, IN 46236 US Other 510(k) Applications for this Company
Contact	KAY TAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.1315   More FDA Info for this Regulation Number
Classification Product Code	KQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2010
Decision Date	06/11/2010
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