Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name brain trauma assessment test
510(k) Number K234143
Device Name i-STAT TBI Cartridge with the i-STAT Alinity System
Applicant
Abbott Point of Care
400 College Road East
Princeton,  NJ  08540
Applicant Contact Brian Ma
Correspondent
Abbott Point of Care
400 College Road East
Princeton,  NJ  08540
Correspondent Contact Brian Ma
Regulation Number866.5830
Classification Product Code
QAT  
Subsequent Product Code
JJY  
Date Received12/29/2023
Decision Date 03/27/2024
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
-
-