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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 the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2018-11-30 under 510(k) 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. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K182391.

When did ASI Automated ASI RPR Test for Syphilis on the ASI Evolution receive FDA 510(k) clearance?

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

Who is the listed applicant for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

The FDA 510(k) record lists Arlington Scientific, Inc. (Asi) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Arlington Scientific, Inc. (Asi) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerK173376ASI Evolution

Related Devices (Code: GMQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLCK201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)

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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