The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Model 795 Fluorometer/densitometer.
| Device ID | K915332 |
| 510k Number | K915332 |
| Device Name: | MODEL 795 FLUOROMETER/DENSITOMETER |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J.pignato |
| Correspondent | William J.pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-02-18 |