FDA 510(k) Application Details - K951457

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K951457
Device Name	Glucose Oxidase, Glucose
Applicant	CLINICAL DIAGNOSTICS, INC. 132 MAIN STREET, SUITE A CHESTER, SC 29706 US Other 510(k) Applications for this Company
Contact	CHARLES F NEILSON 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	03/29/1995
Decision Date	02/22/1996
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