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510(k) K112528

ELECSYS T4 CALCHECK 5 by Roche Diagnostics Corporation — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2011
Date Received
August 31, 2011
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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