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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 K230790
Device Name Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
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
CEM   CFR   CGZ   JGS   JJE  
Date Received03/22/2023
Decision Date 05/19/2023
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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