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510(k) K101852

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT by Iris International Inc., A Division of Iris Iris I — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2011
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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