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510(k) K070910

SYSMEX MODEL UF1000I by Sysmex America, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2007
Date Received
April 2, 2007
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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