The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays.
| Device ID | K040120 |
| 510k Number | K040120 |
| Device Name: | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | David M Ikeda |
| Correspondent | David M Ikeda DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2005-04-29 |
| Summary: | summary |