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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, Calcium
510(k) Number K230300
Device Name i-STAT CG8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Applicant Contact Brian Ma
Correspondent
Abbott Point of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Correspondent Contact Brian Ma
Regulation Number862.1145
Classification Product Code
JFP  
Subsequent Product Code
JPI  
Date Received02/03/2023
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
Predetermined Change
Control Plan Authorized		 No
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