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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 K243283
Device Name Alinity h-series System
Applicant
Abbott Laboratories
4551 Great America Pkwy.
Santa Clara,  CA  95054
Applicant Contact Saloni Shah
Correspondent
Abbott Laboratories
4551 Great America Pkwy.
Santa Clara,  CA  95054
Correspondent Contact Saloni Shah
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
KPA  
Date Received10/17/2024
Decision Date 02/20/2025
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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