Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IDS SHBG

K-Number: K190121 · 2019-06-17

Decision Date2019-06-17
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS SHBG is a medical device manufactured by Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2019-06-17 under approval 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. It is manufactured by Immunodiagnostic Systems , Ltd.. The 510(k) number is K190121.

When was IDS SHBG approved by the FDA?

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

What company makes IDS SHBG?

IDS SHBG is manufactured by Immunodiagnostic Systems , Ltd..

What is the FDA product code for IDS SHBG?

The FDA product code for IDS SHBG is CDZ.

Other Devices by Immunodiagnostic Systems , Ltd.

Related Devices (Code: CDZ)

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.