FDA 510(k) Application Details - K000102

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K000102
Device Name	Hexokinase, Glucose
Applicant	TECO DIAGNOSTICS 4925 EAST HUNTER AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	DINDO CARRILLO 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	01/13/2000
Decision Date	02/08/2000
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