Home / 510(k) Clearances / K140971

510(k) K140971

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. by Randox Laboratories Limited — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2014
Date Received
April 16, 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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