The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Lyme Igm, Liaison Lyme Igm Control Set, Liaison Lyme Total Antibody Plus.
| Device ID | K202573 |
| 510k Number | K202573 |
| Device Name: | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 |
| Contact | John C Walter |
| Correspondent | Carol A Depouw DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2021-02-18 |