Clearance Summary
LH (125I) RADIOIMMUNOASSAY received FDA 510(k) clearance under submission number K822288, 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 1982-09-13.
- Submission: K822288
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1982-09-13
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.