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510(k) K133330

C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN by Roche Diagnostics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2013
Date Received
November 1, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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