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510(k) K053135

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER by Sysmex America, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2006
Date Received
November 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Urine Particle
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

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