FDA 510(k) Application Details - K021781

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K021781
Device Name	Glucose Oxidase, Glucose
Applicant	CHAY MEDICAL, LLC. 3257 ROUTE 128 CALISTOGA, CA 94515 US Other 510(k) Applications for this Company
Contact	STEPHEN C PEARSON 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	05/30/2002
Decision Date	08/30/2002
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