The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Vzv Igg.
| Device ID | K061820 |
| 510k Number | K061820 |
| Device Name: | DIASORIN LIAISON VZV IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mari Meyer |
| Correspondent | Mari Meyer DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2007-02-26 |
| Summary: | summary |