FDA 510(k) Application Details - K963544

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K963544
Device Name	Glucose Oxidase, Glucose
Applicant	CHRONIMED, INC. 6214 BURY DR. EDEN PRAIRIE, MN 55346 US Other 510(k) Applications for this Company
Contact	JEFFREY P HEATON 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	09/04/1996
Decision Date	02/20/1997
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