The following data is part of a premarket notification filed by Arlington Scientific, Inc. (asi) with the FDA for Asi Automated Asi Rpr Test For Syphilis On The Asi Evolution.
| Device ID | K182391 |
| 510k Number | K182391 |
| Device Name: | ASI Automated ASI RPR Test For Syphilis On The 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 | 2018-09-04 |
| Decision Date | 2018-11-30 |
| Summary: | summary |