Arlington Scientific, Inc. (Asi)
Springville, UT, US
Arlington Scientific, Inc. (Asi) appears in FDA device records in Springville, UT. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 3
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 3 510(k) clearances for Arlington Scientific, Inc. (Asi) between 2018 and 2020. The busiest year on record is 2018, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | GMQ | Substantially Equivalent | |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | GMQ | Substantially Equivalent | |
| K173376 | ASI Evolution | GMQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain