Clearance Summary
BIOCLONES ELEGANCE LH ELISA KIT received FDA 510(k) clearance under submission number K904387, 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 1990-11-06.
- Submission: K904387
- Applicant / Sponsor: Bioclone Australia Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1990-11-06
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.