FDA 510(k) Application Details - K071649

Device Classification Name	Enzymatic Methods, Galactose   More FDA Info for this Device
510(K) Number	K071649
Device Name	Enzymatic Methods, Galactose
Applicant	WALLAC OY 940 WINTER STREET WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	CINDY LLOYD 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	06/18/2007
Decision Date	08/07/2008
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