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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, sodium
510(k) Number K230275
Device Name i-STAT CG8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care Inc.
400 College Road East
Princeton,  NJ  08540
Applicant Contact Brian Ma
Correspondent
Abbott Point of Care Inc.
400 College Road East
Princeton,  NJ  08540
Correspondent Contact Brian Ma
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Code
CEM  
Date Received02/01/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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