FDA 510(k) Application Details - K180296

Device Classification Name	More FDA Info for this Device
510(K) Number	K180296
Device Name	Afinion HbA1c Dx
Applicant	Alere Technologies AS Kjelsaasveien 161 Oslo NO-0884 NO Other 510(k) Applications for this Company
Contact	Monica Vallestad 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	02/02/2018
Decision Date	05/07/2018
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