ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer— 510(k) K201438
Substantially EquivalentArlington Scientific, Inc. (Asi)
FDA 510(k) clearance K201438 for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, Substantially Equivalent on 2020-10-21. Applicant: Arlington Scientific, Inc. (Asi). Device class: 2.
Clearance details
- Applicant
- Arlington Scientific, Inc. (Asi)
- Product code
- Code GMQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3820
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Springville, UT, US
Recent devices under product code GMQ
view all- K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
- K173376 — ASI Evolution
- K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.