The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 780 Fluorometer/densitometer.
| Device ID | K850617 |
| 510k Number | K850617 |
| Device Name: | CORNING 780 FLUOROMETER/DENSITOMETER |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-03-12 |