The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Borrelia Igg/igm Assay, Model 310870; Serum Controls, Model 310871.
| Device ID | K062473 |
| 510k Number | K062473 |
| Device Name: | LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 |
| Classification | Reagent, Borrelia Serological Reagent |
| 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 | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2007-04-12 |
| Summary: | summary |