FDA 510(k) Application Details - K994433

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K994433
Device Name	Glucose Dehydrogenase, Glucose
Applicant	ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP DR. ALAMEDA, CA 94502-7000 US Other 510(k) Applications for this Company
Contact	EVE A CONNER Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	LFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1999
Decision Date	05/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review