FDA 510(k) Application Details - K990654

Device Classification Name	Enzymatic Methods, Galactose   More FDA Info for this Device
510(K) Number	K990654
Device Name	Enzymatic Methods, Galactose
Applicant	QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD PERTH, SCOTLAND PH2 8DF GB Other 510(k) Applications for this Company
Contact	R. STEWART CAMPBELL 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	03/01/1999
Decision Date	06/21/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review