ASI Automated ASI RPR Test for Syphilis on the ASI Evolution— 510(k) K182391
Substantially EquivalentArlington Scientific, Inc. (Asi)
FDA 510(k) clearance K182391 for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution, Substantially Equivalent on 2018-11-30. 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
- K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- 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.