Clearance Summary
IMMOPHASE TM HPL RADIOIMMUNOASSAY received FDA 510(k) clearance under submission number K823292, 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 1982-12-28.
- Submission: K823292
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1585
- Decision date: 1982-12-28
Classification & Regulation
This clearance is catalogued under FDA product code JMF and 21 CFR 862.1585, within the Clinical Chemistry review panel as a Class II device.