Clearance Summary
BIOCLONE'S ELEGANCE HCG ELISA KIT received FDA 510(k) clearance under submission number K910420, 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 1991-02-26.
- Submission: K910420
- Applicant / Sponsor: Bioclone Australia Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1991-02-26
Classification & Regulation
This clearance is catalogued under FDA product code JHI and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.