The following data is part of a premarket notification filed by Arlington Scientific, Inc. (asi) with the FDA for Asi Evolution.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASI EVOLUTION 86974304 5247353 Live/Registered |
ASI HOLDING CO., LP 2016-04-13 |