K172722 is an FDA 510(k) clearance for the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM). This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on December 10, 2017, 90 days after receiving the submission on September 11, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K172722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2017 |
| Decision Date | December 10, 2017 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |