FDA 510(k) Application Details - K171771

Device Classification Name	More FDA Info for this Device
510(K) Number	K171771
Device Name	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Applicant	Siemens Healthcare Diagnostics Inc. 500 GBC Drive Newark, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	Alan Haley 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	06/14/2017
Decision Date	12/04/2017
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