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FDA 510(k)

IDS-iSYS Free Testosterone

K-Number: K240865 · 2024-10-23

ApplicantImmunodiagnostic Systems Limited
Decision Date2024-10-23
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS-iSYS Free Testosterone is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K240865. 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 IDS-iSYS Free Testosterone?

IDS-iSYS Free Testosterone is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Immunodiagnostic Systems Limited. The 510(k) number is K240865.

When did IDS-iSYS Free Testosterone receive FDA 510(k) clearance?

IDS-iSYS Free Testosterone received FDA 510(k) clearance on 2024-10-23, under 510(k) number K240865.

Who is the listed applicant for IDS-iSYS Free Testosterone?

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

What is the FDA product code for IDS-iSYS Free Testosterone?

The FDA product code for IDS-iSYS Free Testosterone is CDZ.

Other records listing Immunodiagnostic Systems Limited as applicant

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 TestosteroneK223867IDS ACTH IIK202136IDS CortisolK200475IDS-iSYS Ostase BAPK190121IDS SHBGK161158IDS-iSYS Intact PTHN

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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 LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON 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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