The following data is part of a premarket notification filed by Viramed Biotech Ag with the FDA for Borrelia B31 Virachip Igm Test Kit.
| Device ID | K163695 |
| 510k Number | K163695 |
| Device Name: | Borrelia B31 ViraChip IgM Test Kit |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Viramed Biotech AG Behringstrasse 11 Planegg, DE 82152 |
| Contact | Martin Kintrup |
| Correspondent | Barry E Menefee Viralab Inc. 105 Copperwood Way Suite H Oceanside, CA 92058 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-28 |
| Decision Date | 2017-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EVIRBBCMOK1 | K163695 | 000 |
| EVIRBBCMDK1 | K163695 | 000 |