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FDA 510(k)

Elecsys Vitamin D total III

K-Number: K210901 · 2021-09-01

ApplicantRoche Diagnostics
Decision Date2021-09-01
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Vitamin D total III is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2021-09-01 under approval number K210901. 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 III?

Elecsys Vitamin D total III is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Roche Diagnostics. The 510(k) number is K210901.

When was Elecsys Vitamin D total III approved by the FDA?

Elecsys Vitamin D total III received FDA 510(k) clearance on 2021-09-01, under approval number K210901.

What company makes Elecsys Vitamin D total III?

Elecsys Vitamin D total III is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Vitamin D total III?

The FDA product code for Elecsys Vitamin D total III is MRG.

Related Clinical Trials

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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