FDA 510(k) Application Details - K973140

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K973140
Device Name	Glucose Oxidase, Glucose
Applicant	LXN CORP. 5830 OBERLIN DR. SUITE 102 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	VIVIANNE T NOETZEL 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	08/21/1997
Decision Date	10/31/1997
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