Clearance Summary
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY received FDA 510(k) clearance under submission number K833406, 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 1984-01-24.
- Submission: K833406
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1280
- Decision date: 1984-01-24
Classification & Regulation
This clearance is catalogued under FDA product code CGF and 21 CFR 862.1280, within the Clinical Chemistry review panel as a Class I device.