The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Vzv Igg, Liaison Control Vzv Igg.
| Device ID | K150375 |
| 510k Number | K150375 |
| Device Name: | LIAISON VZV IgG, LIAISON Control VZV IgG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 |
| Contact | John Walter |
| Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-03-11 |
| Summary: | summary |