The following data is part of a premarket notification filed by Viramed Biotech Ag with the FDA for Viramed Borrela All-in-one Virachip Test Kit.
| Device ID | K220016 |
| 510k Number | K220016 |
| Device Name: | Viramed Borrela All-In-One ViraChip Test Kit |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Viramed Biotech AG Behringstrasse 11 Planegg, DE 82152 |
| Contact | Martin Kintrup |
| Correspondent | Leonard Rollins Viralab Inc. 1815 14th St. NW Suite D Rochester, MN 55901 -0758 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EVIRBTCFOK1 | K220016 | 000 |
| EVIRBTCFDK1 | K220016 | 000 |