Source document or public record
FDA 510(k) K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
FDA 510(k) index record K201438. Device: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer. Applicant as listed: Arlington Scientific, Inc. (Asi). Decision date: 2020-10-21.
Source
"device_name": "ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201438.
Device name: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer. Applicant as listed: Arlington Scientific, Inc. (Asi).
Decision date: 2020-10-21. Decision wording: Substantially Equivalent.
Product code: GMQ. Regulation: 21 CFR 866.3820. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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