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510(k) K150330

Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) by ACON Laboratories, Inc. — Product Code JIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2015
Date Received
February 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

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