Clearance Summary
IMMO PHASE FT4 ASSAY received FDA 510(k) clearance under submission number K772194, sponsored by Corning Medical & Scientific. 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 1978-01-06.
- Submission: K772194
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 1978-01-06
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.