Cleared Traditional

K173376: ASI Evolution

K173376 · Arlington Scientific, Inc. (Asi) · Microbiology
Jun 2018
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K173376 is an FDA 510(k) clearance for the ASI Evolution, a Antigens, Nontreponemal, All (Class II — Special Controls, product code GMQ), submitted by Arlington Scientific, Inc. (Asi) (Springville, US). The FDA issued a Cleared decision on June 14, 2018, 227 days after receiving the submission on October 30, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K173376 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2017
Decision Date June 14, 2018
Days to Decision 227 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GMQ — Antigens, Nontreponemal, All
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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