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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, human chorionic gonadotropin
510(k) Number K230937
Device Name Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Applicant
Abbott Laboratories
1915 Hurd Drive
Irving,  TX  75038
Applicant Contact Melissa Vaughan
Correspondent
Abbott Laboratories
1915 Hurd Drive
Irving,  TX  75038
Correspondent Contact Melissa Vaughan
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Codes
JJE   JQP  
Date Received04/03/2023
Decision Date 06/05/2023
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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