FDA 510(k) Application Details - K002624

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K002624
Device Name	Glucose Oxidase, Glucose
Applicant	APEX BIOTECHNOLOGY CORP. 3600 HOLLY LN. N. SUITE 90 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	STEVEN CREES Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2000
Decision Date	01/22/2001
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