The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Treponema Assay.
| Device ID | K061247 |
| 510k Number | K061247 |
| Device Name: | DIASORIN LIAISON TREPONEMA ASSAY |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-07-31 |
| Summary: | summary |