FDA 510(k) Application Details - K121101

Device Classification Name	Enzymatic Methods, Galactose   More FDA Info for this Device
510(K) Number	K121101
Device Name	Enzymatic Methods, Galactose
Applicant	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US Other 510(k) Applications for this Company
Contact	CHARLES A PETERSON Other 510(k) Applications for this Contact
Regulation Number	862.1310   More FDA Info for this Regulation Number
Classification Product Code	JIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2012
Decision Date	06/20/2013
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