FDA 510(k) Application Details - K201778

Device Classification Name	More FDA Info for this Device
510(K) Number	K201778
Device Name	i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Applicant	Abbott Laboratories 400 College Road East Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Brian Ma Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2020
Decision Date	01/08/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review