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FDA 510(k)

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

K-Number: K182391 · 2018-11-30

ApplicantArlington Scientific, Inc. (Asi)
Decision Date2018-11-30
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is a medical device manufactured by Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2018-11-30 under approval number K182391. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Arlington Scientific, Inc. (Asi). The 510(k) number is K182391.

When was ASI Automated ASI RPR Test for Syphilis on the ASI Evolution approved by the FDA?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution received FDA 510(k) clearance on 2018-11-30, under approval number K182391.

What company makes ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is manufactured by Arlington Scientific, Inc. (Asi).

What is the FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

The FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is GMQ.

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Other Devices by Arlington Scientific, Inc. (Asi)

K173376ASI Evolution K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

Related Devices (Code: GMQ)

K173376ASI EvolutionArlington Scientific, Inc. (Asi) K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi) K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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