The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Elvi 655 Flame Photometer.
Device ID | K843375 |
510k Number | K843375 |
Device Name: | ELVI 655 FLAME PHOTOMETER |
Classification | Flame Emission Photometer For Clinical Use |
Applicant | LOGOS SCIENTIFIC, INC. 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 | 1984-08-28 |
Decision Date | 1985-05-20 |