Clearance Summary
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T received FDA 510(k) clearance under submission number K020156, 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 2002-03-06.
- Submission: K020156
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2002-03-06
Classification & Regulation
This clearance is catalogued under FDA product code MID and 21 CFR 866.5660, within the Immunology review panel as a Class II device.