The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison(r) Toxo Igg Ii, Liaison(r) Control Toxo Igg Ii.
| Device ID | K132234 |
| 510k Number | K132234 |
| Device Name: | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE PO BOX 285 Stillwater, MN 55082 -0285 |
| Contact | John Eskdale |
| Correspondent | John Eskdale DIASORIN, INC. 1951 NORTHWESTERN AVE PO 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 | 2013-07-18 |
| Decision Date | 2013-08-28 |
| Summary: | summary |