Clearance Summary
RIANEN, VITAMIN B12 ASSAY SYSTEM received FDA 510(k) clearance under submission number K792175, sponsored by New England Nuclear. 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 1979-11-13.
- Submission: K792175
- Applicant / Sponsor: New England Nuclear
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 1979-11-13
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.