Cleared Traditional

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

K140790 · Siemens Healthcare Diagnostics · Chemistry
Jun 2015
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K140790 is an FDA 510(k) clearance for the Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG), a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on June 15, 2015, 441 days after receiving the submission on March 31, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K140790 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2014
Decision Date June 15, 2015
Days to Decision 441 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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