Clearance Summary
ELEGANCE FT4 ELISA received FDA 510(k) clearance under submission number K922284, sponsored by Bioclone Australia Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1992-07-10.
- Submission: K922284
- Applicant / Sponsor: Bioclone Australia Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 1992-07-10
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.