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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 K210127
Device Name iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Applicant
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact Marisa Pugliese
Correspondent
Beckman Coulter, Inc.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact Marisa Pugliese
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Codes
GKL   JIL   KQO  
Date Received01/19/2021
Decision Date 07/02/2021
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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