FDA 510(k) Application Details - K101392

Device Classification Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase   More FDA Info for this Device
510(K) Number	K101392
Device Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Applicant	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US Other 510(k) Applications for this Company
Contact	JASON C REYNOLDS 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	05/18/2010
Decision Date	02/04/2011
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