Clearance Summary
ELEGANCE NEONATAL TSH ELISA received FDA 510(k) clearance under submission number K935049, 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 1994-10-03.
- Submission: K935049
- Applicant / Sponsor: Bioclone Australia Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1994-10-03
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.