The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Elvi 146 Seroscan.
| Device ID | K842313 |
| 510k Number | K842313 |
| Device Name: | ELVI 146 SEROSCAN |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | LOGOS SCIENTIFIC, INC. 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 | 1984-06-12 |
| Decision Date | 1984-09-10 |