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510(k) K140393

RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 by Randox Laboratories Limited — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2014
Date Received
February 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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