FDA 510(k) Application Details - K163342

Device Classification Name	Device, Hematocrit Measuring   More FDA Info for this Device
510(K) Number	K163342
Device Name	Device, Hematocrit Measuring
Applicant	Abbott Laboratories 400 College Road East Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Tamara McCaw Other 510(k) Applications for this Contact
Regulation Number	864.6400   More FDA Info for this Regulation Number
Classification Product Code	JPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2016
Decision Date	08/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review