The following data is part of a premarket notification filed by Arlington Scientific, Inc. (asi) with the FDA for Asi Automated Rpr (rapid Plasma Reagin) Test For Syphilis, For Use On The Asi Evolution Automated Syphilis Analyzer.
| Device ID | K201438 |
| 510k Number | K201438 |
| Device Name: | ASI Automated RPR (rapid Plasma Reagin) Test For Syphilis, For Use On The ASI Evolution Automated Syphilis Analyzer |
| 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 | 2020-06-01 |
| Decision Date | 2020-10-21 |