Clearance Summary
FLOUROMETER/DENSITOMETER MODEL 720 received FDA 510(k) clearance under submission number K770026, 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 1977-01-26.
- Submission: K770026
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2400
- Decision date: 1977-01-26
Classification & Regulation
This clearance is catalogued under FDA product code JQT and 21 CFR 862.2400, within the Clinical Chemistry review panel as a Class I device.