FDA 510(k) Application Details - K070960

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K070960
Device Name	Glucose Oxidase, Glucose
Applicant	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454-9141 US Other 510(k) Applications for this Company
Contact	PAUL W MACDONALD 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	04/05/2007
Decision Date	07/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review