FDA 510(k) Application Details - K171861

Device Classification Name	More FDA Info for this Device
510(K) Number	K171861
Device Name	CAPILLARYS Hb A1c
Applicant	Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 US Other 510(k) Applications for this Company
Contact	Karen Anderson 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	06/22/2017
Decision Date	02/07/2018
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