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 a medical device manufactured by Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2024-10-23 under approval 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. It is manufactured by Immunodiagnostic Systems Limited. The 510(k) number is K240865.
When was IDS-iSYS Free Testosterone approved by the FDA?
IDS-iSYS Free Testosterone received FDA 510(k) clearance on 2024-10-23, under approval number K240865.
What company makes IDS-iSYS Free Testosterone?
IDS-iSYS Free Testosterone is manufactured by Immunodiagnostic Systems Limited.
What is the FDA product code for IDS-iSYS Free Testosterone?
The FDA product code for IDS-iSYS Free Testosterone is CDZ.
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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.