FDA 510(k) Application Details - K001092

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K001092
Device Name	Glucose Oxidase, Glucose
Applicant	INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	ESTELA I RAYCHAUDHURI 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	04/04/2000
Decision Date	07/26/2000
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