Cleared Traditional

AUTION CHECK PLUS

K142262 · Quantimetrix Corp. · Chemistry
Apr 2015
Decision
239d
Days
Class 1
Risk

About This 510(k) Submission

K142262 is an FDA 510(k) clearance for the AUTION CHECK PLUS, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on April 10, 2015, 239 days after receiving the submission on August 14, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K142262 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2014
Decision Date April 10, 2015
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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