ACTIVE® Free Testosterone RIA
K-Number: K191350 · 2019-12-20
ApplicantImmunotech S.R.O.
Decision Date2019-12-20
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ACTIVE® Free Testosterone RIA is a medical device manufactured by Immunotech S.R.O.. It received FDA 510(k) clearance on 2019-12-20 under approval number K191350. 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 ACTIVE® Free Testosterone RIA?
ACTIVE® Free Testosterone RIA is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Immunotech S.R.O.. The 510(k) number is K191350.
When was ACTIVE® Free Testosterone RIA approved by the FDA?
ACTIVE® Free Testosterone RIA received FDA 510(k) clearance on 2019-12-20, under approval number K191350.
What company makes ACTIVE® Free Testosterone RIA?
ACTIVE® Free Testosterone RIA is manufactured by Immunotech S.R.O..
What is the FDA product code for ACTIVE® Free Testosterone RIA?
The FDA product code for ACTIVE® Free Testosterone RIA 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.