FDA 510(k) Application Details - K162822

Device Classification Name	More FDA Info for this Device
510(K) Number	K162822
Device Name	ADAMS A1c HA-8180V, CALIBRATOR 80
Applicant	Arkray Factory, Inc. 1480 Koji, Konan-cho Koka-shi 520-3306 JP Other 510(k) Applications for this Company
Contact	Kazuya Yorimitsu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2016
Decision Date	06/29/2017
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