The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Lyme Screen Ii.
| Device ID | K943812 |
| 510k Number | K943812 |
| Device Name: | VIDAS LYME SCREEN II |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Terry Mcgovern |
| Correspondent | Terry Mcgovern BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1995-06-13 |