The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Ea Igg.
| Device ID | K060204 |
| 510k Number | K060204 |
| Device Name: | LIAISON EA IGG |
| Classification | Epstein-barr Virus, Other |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | David M Ikeda |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-26 |
| Decision Date | 2006-10-18 |
| Summary: | summary |