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510(k) K121588

RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 by Randox Laboratories, Ltd. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
May 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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