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FDA 510(k)

Elecsys Testosterone II

K-Number: K211685 · 2022-05-06

ApplicantRoche Diagnostics
Decision Date2022-05-06
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Testosterone II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-05-06 under approval number K211685. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Testosterone II?

Elecsys Testosterone II is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Roche Diagnostics. The 510(k) number is K211685.

When was Elecsys Testosterone II approved by the FDA?

Elecsys Testosterone II received FDA 510(k) clearance on 2022-05-06, under approval number K211685.

What company makes Elecsys Testosterone II?

Elecsys Testosterone II is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Testosterone II?

The FDA product code for Elecsys Testosterone II is CDZ.

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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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