FDA 510(k) Application Details - K163078

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K163078
Device Name	Calibrator, Secondary
Applicant	SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE CHARLOTTETOWN C1E 2B9 CA Other 510(k) Applications for this Company
Contact	PENNY WHITE Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2016
Decision Date	12/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review