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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 K191595
Device Name ARCHITECT STAT High Sensitivity Troponin-I
Applicant
Abbott Laboratories Diagnostics Division
Dept. 09AA, Bldg. AP8, 100 Abbott Park Road
Abbott Park,  IL  60064 -6038
Applicant Contact Judi Wallach
Correspondent
Abbott Laboratories Diagnostics Division
Dept. 09AA, Bldg, AP8, 100 Abbott Park Road
Abbott Park,  IL  60064 -6038
Correspondent Contact Judi Wallach
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/17/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01608100
Reviewed by Third Party No
Combination Product No
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