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.
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Official Source
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