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510(k) K121603

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 by Randox Laboratories, Ltd. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2012
Date Received
April 6, 2012
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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