The following data is part of a premarket notification filed by Arlington Scientific, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK170114 |
| 510k Number | BK170114 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| 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 | 2017-09-15 |
| Decision Date | 2017-12-28 |