The following data is part of a premarket notification filed by Arlington Scientific, Inc. with the FDA for Antigens, Nontreponemal, All.
| Device ID | BK200488 |
| 510k Number | BK200488 |
| Device Name: | Antigens, Nontreponemal, All |
| Classification | Antigens, Nontreponemal, All |
| Applicant | Arlington Scientific, Inc. 1840 North Technology Dr. Springville, UT 84663 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2020-09-30 |