The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Toxo Igm Ii, Liaison Control Toxo Igm Ii.
| Device ID | K131441 |
| 510k Number | K131441 |
| Device Name: | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Sandra Zimniewicz |
| Correspondent | Sandra Zimniewicz DIASORIN, INC. 1951 NORTHWESTERN AVE. 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 | 2013-05-20 |
| Decision Date | 2013-08-09 |
| Summary: | summary |