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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-05-06 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K211685.

When did Elecsys Testosterone II receive FDA 510(k) clearance?

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

Who is the listed applicant for Elecsys Testosterone II?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Testosterone II?

The FDA product code for Elecsys Testosterone II is CDZ.

Other records listing Roche Diagnostics as applicant

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Related Devices (Code: CDZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K201908LIAISON Testosterone xtDiaSorin, Inc.K191350ACTIVE® Free Testosterone RIAImmunotech S.R.O.

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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