K122979 is an FDA 510(k) clearance for the VIDAS LYME IGM. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Biomerieux S.A. (Marcy L Etoile, FR). The FDA issued a Cleared decision on June 4, 2013, 251 days after receiving the submission on September 26, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K122979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2012 |
| Decision Date | June 04, 2013 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |