Clearance Summary
VIEWER, FLUOROMETIC, MODEL 721 received FDA 510(k) clearance under submission number K770662, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1977-04-15.
- Submission: K770662
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4520
- Decision date: 1977-04-15
Classification & Regulation
This clearance is catalogued under FDA product code JZT and 21 CFR 866.4520, within the Immunology review panel as a Class I device.