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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K220031
Device Name Alinity h-series System
Applicant
Abbott Laboratories
4551 Great America Pkwy
Santa Clara,  CA  95054
Applicant Contact Neha Vatsyayan
Correspondent
Abbott Laboratories
4551 Great America Pkwy
Santa Clara,  CA  95054
Correspondent Contact Neha Vatsyayan
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
KPA  
Date Received01/05/2022
Decision Date 08/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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