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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K202525
Device Name Alinity i STAT High Sensitivity Troponin-I
Applicant
Abbott Laboratories Diagnostics Division
Dept. 9aa, Cp01-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -6038
Applicant Contact Judi Wallach
Correspondent
Abbott Laboratories Diagnostics Division
Dept. 9aa, Cp01-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -6038
Correspondent Contact Judi Wallach
Regulation Number862.1215
Classification Product Code
MMI  
Date Received09/01/2020
Decision Date 05/19/2022
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
Predetermined Change
Control Plan Authorized		 No
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