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510(k) K113720

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 by Randox Laboratories, Ltd. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
December 19, 2011
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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