The following data is part of a premarket notification filed by Diasorin S.p.a. with the FDA for Diasorin Liaison Toxo Igg And Liaison Toxo Igm Assays.
| Device ID | K052499 |
| 510k Number | K052499 |
| Device Name: | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Mari A Meyer |
| Correspondent | Mari A Meyer DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2006-02-08 |
| Summary: | summary |