The following data is part of a premarket notification filed by Diasorin S.p.a. with the FDA for Diasorin Liaison Cmv Igm/igg.
| Device ID | K040290 |
| 510k Number | K040290 |
| Device Name: | DIASORIN LIAISON CMV IGM/IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | David M Ikeda |
| Correspondent | David M Ikeda DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2005-06-01 |
| Summary: | summary |