Clearance Summary
FLAME PHOTOMETER, MODEL 435 received FDA 510(k) clearance under submission number K780649, 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 1978-05-26.
- Submission: K780649
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2540
- Decision date: 1978-05-26
Classification & Regulation
This clearance is catalogued under FDA product code JJO and 21 CFR 862.2540, within the Clinical Chemistry review panel as a Class I device.