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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 K961054
Device Name SYSMEX UF-100
Applicant
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047 -9596
Applicant Contact NINA GAMPERLING
Correspondent
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047 -9596
Correspondent Contact NINA GAMPERLING
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Codes
JIW   JJW  
Date Received03/18/1996
Decision Date 10/28/1996
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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