510(k) K201438— ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
Substantially EquivalentArlington Scientific, Inc. (Asi)
Clearance details
- Applicant
- Arlington Scientific, Inc. (Asi)
- Product code
- Code GMQ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Springville, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.