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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K203597
Device Name Cholesterol2
Applicant
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Applicant Contact Tracy Schmidt
Correspondent
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Correspondent Contact Tracy Schmidt
Regulation Number862.1175
Classification Product Code
CHH  
Date Received12/09/2020
Decision Date 06/30/2022
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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