Cleared Traditional

Audit MicroControls Linearity LQ Special Diabetes

K142978 · Aalto Scientific, Ltd. · Chemistry
Nov 2014
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K142978 is an FDA 510(k) clearance for the Audit MicroControls Linearity LQ Special Diabetes, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 20, 2014, 36 days after receiving the submission on October 15, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K142978 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2014
Decision Date November 20, 2014
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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