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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 K240252
Device Name UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
Applicant
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact Marie Steigerwalt
Correspondent
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact Marie Steigerwalt
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
KPA  
Date Received01/30/2024
Decision Date 07/05/2024
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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