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510(k) K131554

RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT by Randox Laboratories, Ltd. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2014
Date Received
May 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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