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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name brain trauma assessment test
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
Applicant Contact Brian Ma
Correspondent
Abbott Laboratories
400 College Road East
Princeton,  NJ  08540
Correspondent Contact Brian Ma
Regulation Number866.5830
Classification Product Code
QAT  
Date Received06/30/2020
Decision Date 01/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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