FDA 510(k) Application Details - K092506

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K092506
Device Name	Hexokinase, Glucose
Applicant	MEDICA CORP. 5 OAK PARK DRIVE BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Photios Makris Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2009
Decision Date	09/16/2009
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