FDA 510(k) Application Details - K200256

Device Classification Name	More FDA Info for this Device
510(K) Number	K200256
Device Name	ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Applicant	Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Julie Warren 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	02/03/2020
Decision Date	07/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review