Clearance Summary
IMMO PHASE FSH RADIOIMMUNOASSAY received FDA 510(k) clearance under submission number K822227, 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 1982-08-16.
- Submission: K822227
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1300
- Decision date: 1982-08-16
Classification & Regulation
This clearance is catalogued under FDA product code CGJ and 21 CFR 862.1300, within the Clinical Chemistry review panel as a Class I device.