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FDA 510(k)

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

K-Number: K162840 · 2017-02-08

ApplicantRoche Diagnostics
Decision Date2017-02-08
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-02-08 under approval number K162840. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5?

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Roche Diagnostics. The 510(k) number is K162840.

When was Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 approved by the FDA?

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 received FDA 510(k) clearance on 2017-02-08, under approval number K162840.

What company makes Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5?

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5?

The FDA product code for Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 is MRG.

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NCT07150221 MDR Vivacit-E Elevated Study ENROLLING_BY_INVITATION

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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