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FDA 510(k)

IDS SHBG

K-Number: K190121 · 2019-06-17

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2019-06-17
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS SHBG is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K190121. 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 SHBG?

IDS SHBG is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K190121.

When did IDS SHBG receive FDA 510(k) clearance?

IDS SHBG received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190121.

Who is the listed applicant for IDS SHBG?

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

What is the FDA product code for IDS SHBG?

The FDA product code for IDS SHBG is CDZ.

Other records listing Immunodiagnostic Systems , Ltd. 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 TestosteroneK240865IDS-iSYS Free TestosteroneK223867IDS ACTH IIK202136IDS CortisolK200475IDS-iSYS Ostase BAPK161158IDS-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 LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, Inc.

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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