The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Vidas Lyme Igg.
| Device ID | K122986 |
| 510k Number | K122986 |
| Device Name: | VIDAS LYME IGG |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BIOMERIEUX SA CHEMIN DE L ORME Marcy L Etoile, FR 69280 |
| Contact | Catherine Fritsch |
| Correspondent | Catherine Fritsch BIOMERIEUX SA CHEMIN DE L ORME Marcy L Etoile, FR 69280 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-26 |
| Decision Date | 2013-03-05 |
| Summary: | summary |