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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 K190294
Device Name CELL-DYN Emerald 22 AL System
Applicant
Abbott Laboratories
4551 Great America Pkwy
Santa Clara,  CA  95054
Applicant Contact Madhu Gill
Correspondent
Abbott Laboratories
4551 Great America Pkwy
Santa Clara,  CA  95054
Correspondent Contact Madhu Gill
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/11/2019
Decision Date 03/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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