FDA 510(k)

ACTIVE® Free Testosterone RIA

K-Number: K191350 · 2019-12-20

Decision Date2019-12-20

Product CodeCDZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACTIVE® Free Testosterone RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech S.R.O.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191350. 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 ACTIVE® Free Testosterone RIA?

ACTIVE® Free Testosterone RIA is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Immunotech S.R.O.. The 510(k) number is K191350.

When did ACTIVE® Free Testosterone RIA receive FDA 510(k) clearance?

ACTIVE® Free Testosterone RIA received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191350.

Who is the listed applicant for ACTIVE® Free Testosterone RIA?

The FDA 510(k) record lists Immunotech S.R.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE® Free Testosterone RIA?

The FDA product code for ACTIVE® Free Testosterone RIA is CDZ.

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 Limited K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited K233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche Diagnostics K201908LIAISON Testosterone xtDiaSorin, Inc.

Official Source

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