Clearance Summary
IMMOPHASE INSULIN (125I) RADIOASSAY received FDA 510(k) clearance under submission number K811953, 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 1981-07-23.
- Submission: K811953
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1405
- Decision date: 1981-07-23
Classification & Regulation
This clearance is catalogued under FDA product code CFP and 21 CFR 862.1405, within the Clinical Chemistry review panel as a Class I device.