The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Flame Photometer, Model 435.
Device ID | K780649 |
510k Number | K780649 |
Device Name: | FLAME PHOTOMETER, MODEL 435 |
Classification | Flame Emission Photometer For Clinical Use |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJO |
CFR Regulation Number | 862.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-19 |
Decision Date | 1978-05-26 |