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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 K012372
Device Name SYSMEX UF-50
Applicant
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047 -9596
Applicant Contact CHRIS STUKEL
Correspondent
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047 -9596
Correspondent Contact CHRIS STUKEL
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Code
GKZ  
Date Received07/26/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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