ASI Evolution
K-Number: K173376 · 2018-06-14
ApplicantArlington Scientific, Inc. (Asi)
Decision Date2018-06-14
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
ASI Evolution is a medical device manufactured by Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2018-06-14 under approval number K173376. 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 Evolution?
ASI Evolution is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Arlington Scientific, Inc. (Asi). The 510(k) number is K173376.
When was ASI Evolution approved by the FDA?
ASI Evolution received FDA 510(k) clearance on 2018-06-14, under approval number K173376.
What company makes ASI Evolution?
ASI Evolution is manufactured by Arlington Scientific, Inc. (Asi).
What is the FDA product code for ASI Evolution?
The FDA product code for ASI Evolution is GMQ.
Other Devices by Arlington Scientific, Inc. (Asi)
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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.