The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Corning 760 Fluorometer/densitometer.
Device ID | K803240 |
510k Number | K803240 |
Device Name: | CORNING 760 FLUOROMETER/DENSITOMETER |
Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
Applicant | TRANSIDYNE GENERAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQT |
CFR Regulation Number | 862.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-23 |
Decision Date | 1981-01-09 |