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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 K183688
Device Name i-STAT CHEM8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care, Inc.
400 College Road East
Princeton,  NJ  08540
Applicant Contact Susan Tibedo
Correspondent
Abbott Point of Care, Inc.
400 College Road East
Princeton,  NJ  08540
Correspondent Contact Susan Tibedo
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CDS   CEM   CGZ  
Date Received12/28/2018
Decision Date 02/07/2020
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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