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510(k) K140790

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) by Siemens Healthcare Diagnostics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2015
Date Received
March 31, 2014
Clearance Type
Traditional
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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