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510(k) K142391

Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) by ACON Laboratories, Inc. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2014
Date Received
August 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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