Clearance Summary
AUTOFLUOR V received FDA 510(k) clearance under submission number K861978, sponsored by Technia 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 1986-06-10.
- Submission: K861978
- Applicant / Sponsor: Technia Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1986-06-10
Classification & Regulation
This clearance is catalogued under FDA product code KTL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.