FDA 510(k) Application Details - K161687

Device Classification Name	More FDA Info for this Device
510(K) Number	K161687
Device Name	D-10 Hemoglobin A1c Program
Applicant	BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US Other 510(k) Applications for this Company
Contact	JACKIE BUCKLEY 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	06/17/2016
Decision Date	10/14/2016
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