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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 K213486
Device Name GLP systems Track
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Michele Smith Waheed
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Michele Smith-Waheed
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JJE   JQP  
Date Received10/29/2021
Decision Date 03/10/2022
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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