Clearance Summary
RIA KIT, VITAMIN B12 received FDA 510(k) clearance under submission number K782024, sponsored by Technia Diagnostics , 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 1979-02-28.
- Submission: K782024
- Applicant / Sponsor: Technia Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 1979-02-28
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.