FDA 510(k) Application Details - K170200

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K170200
Device Name	Enzymatic, Carbon-Dioxide
Applicant	Teco Diagnostics, Inc. 1268 North Lakeview Avenue Anaheim, CA 92807 US Other 510(k) Applications for this Company
Contact	Hyun Bin Song Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2017
Decision Date	06/01/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review