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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
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