The following data is part of a premarket notification filed by American Dade with the FDA for Lectin-a.
| Device ID | K820368 |
| 510k Number | K820368 |
| Device Name: | LECTIN-A |
| Classification | Lectins And Protectins |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSI |
| CFR Regulation Number | 864.9550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-04-14 |