Clearance Summary
ADVIA Centaur Calcitonin (CALCT) assay received FDA 510(k) clearance under submission number K182012, sponsored by Axis-Shield Diagnostics Limited. 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 2018-12-21.
- Submission: K182012
- Applicant / Sponsor: Axis-Shield Diagnostics Limited
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1140
- Decision date: 2018-12-21
Classification & Regulation
This clearance is catalogued under FDA product code JKR and 21 CFR 862.1140, within the Clinical Chemistry review panel as a Class II device.