Cleared Traditional

Audit MicroControls Linearity DROP LQ Blood Glucose

K161874 · Aalto Scientific, Ltd. · Chemistry
Aug 2016
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K161874 is an FDA 510(k) clearance for the Audit MicroControls Linearity DROP LQ Blood Glucose, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Aalto Scientific, Ltd. (Eatonton, US). The FDA issued a Cleared decision on August 10, 2016, 33 days after receiving the submission on July 8, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K161874 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2016
Decision Date August 10, 2016
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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