K163695 is an FDA 510(k) clearance for the Borrelia B31 ViraChip IgM Test Kit. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Viramed Biotech AG (Planegg, DE). The FDA issued a Cleared decision on August 22, 2017, 237 days after receiving the submission on December 28, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K163695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2016 |
| Decision Date | August 22, 2017 |
| Days to Decision | 237 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 |