ASI Evolution
Antigens, Nontreponemal, All
Arlington Scientific, Inc. (ASI)
The following data is part of a premarket notification filed by Arlington Scientific, Inc. (asi) with the FDA for Asi Evolution.
Pre-market Notification Details
| Device ID | K173376 |
| 510k Number | K173376 |
| Device Name: | ASI Evolution |
| Classification | Antigens, Nontreponemal, All |
| Applicant | Arlington Scientific, Inc. (ASI) 1840 North Technology Dr. Springville, UT 84663 |
| Contact | David Binks |
| Correspondent | David Binks Arlington Scientific, Inc. (ASI) 1840 North Technology Dr. Springville, UT 84663 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2018-06-14 |
Trademark Results [ASI Evolution]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASI EVOLUTION 86974304 5247353 Live/Registered |
ASI HOLDING CO., LP 2016-04-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.