FDA 510(k) Application Details - K171650

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K171650
Device Name	Assay, Glycosylated Hemoglobin
Applicant	Abbott Rapid Diagnostics 9975 Summers Ridge Road San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Monica Vallestad 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	06/05/2017
Decision Date	11/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review