The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for 710 Fluorometer/densitometer.
Device ID | K810619 |
510k Number | K810619 |
Device Name: | 710 FLUOROMETER/DENSITOMETER |
Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
Applicant | CORNING MEDICAL & SCIENTIFIC MA |
Product Code | JQT |
CFR Regulation Number | 862.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-09 |
Decision Date | 1981-03-27 |