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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Urine Particle
510(k) Number K252580
Device Name iQ200 Series
Applicant
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact Shilpa Pillai
Correspondent
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact Shilpa Pillai
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Code
KQO  
Date Received08/15/2025
Decision Date 09/10/2025
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
Predetermined Change
Control Plan Authorized		 No
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