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ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI E…
FDA 510(k)Class II (US FDA 510(k))
510(k) K201438
Identifiers
- 510(k) Number
- K201438 FDA 510(k)
- FDA Product Code
- GMQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3820 FDA 510(k)
- Regulation Number
- 866.3820 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI E… by Arlington Scientific, Inc. (Asi) — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201438 | Class II | Active |
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Manufacturer
- Manufacturer
- Arlington Scientific, Inc. (Asi)
Sources (1)
- FDA 510(k) K201438 24 fields · synced Jun 18, 2026