FDA 510(k) Application Details - K214117

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K214117
Device Name	Assay, Glycosylated Hemoglobin
Applicant	Abbott Diagnostics Technologies AS Kjelsasveien 161 Oslo NO-0884 NO Other 510(k) Applications for this Company
Contact	Danial Kirmani Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2021
Decision Date	09/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review