Clearance Summary
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 received FDA 510(k) clearance under submission number K021516, sponsored by Axis-Shield Diagnostics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-07-23.
- Submission: K021516
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2002-07-23
Classification & Regulation
This clearance is catalogued under FDA product code NHX and 21 CFR 866.5775, within the Immunology review panel as a Class II device.