Clearance Summary
CORNING HIGH RESOLUTION PROTEIN ELECTRO received FDA 510(k) clearance under submission number K843397, 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 1984-09-14.
- Submission: K843397
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1630
- Decision date: 1984-09-14
Classification & Regulation
This clearance is catalogued under FDA product code CEF and 21 CFR 862.1630, within the Clinical Chemistry review panel as a Class I device.