K850617 is an FDA 510(k) clearance for the CORNING 780 FLUOROMETER/DENSITOMETER. This device is classified as a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I - General Controls, product code JQT).
Submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on March 12, 1985, 25 days after receiving the submission on February 15, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2400.
| 510(k) Number | K850617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1985 |
| Decision Date | March 12, 1985 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2400 |