The following data is part of a premarket notification filed by Gilford with the FDA for Eia Rubella.
| Device ID | K812787 |
| 510k Number | K812787 |
| Device Name: | EIA RUBELLA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | GILFORD 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-05 |
| Decision Date | 1981-11-27 |