Clearance Summary
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY received FDA 510(k) clearance under submission number K812227, sponsored by Clinical Assays, Inc.. 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 1981-09-24.
- Submission: K812227
- Applicant / Sponsor: Clinical Assays, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1405
- Decision date: 1981-09-24
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.