Clearance Summary
ACTIVE® Free Testosterone RIA received FDA 510(k) clearance under submission number K191350, sponsored by Immunotech S.R.O.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2019-12-20.
- Submission: K191350
- Applicant / Sponsor: Immunotech S.R.O.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 2019-12-20
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.