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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Hematocrit Measuring
510(k) Number K183680
Device Name i-STAT CHEM8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Applicant Contact Susan Tibedo
Correspondent
Abbott Point of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Correspondent Contact Susan Tibedo
Regulation Number864.6400
Classification Product Code
JPI  
Date Received12/28/2018
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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