The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Lyme Total Antibody Plus, Liaison Lyme Total Antibody Plus Control Set.
| Device ID | K193051 |
| 510k Number | K193051 |
| Device Name: | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285 |
| Contact | John C. Walter |
| Correspondent | Mari Meyer DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-01-29 |
| Summary: | summary |