Cleared Traditional

Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

K143026 · Aalto Scientific, Ltd. · Chemistry
Nov 2014
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K143026 is an FDA 510(k) clearance for the Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 21, 2014, 31 days after receiving the submission on October 21, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K143026 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2014
Decision Date November 21, 2014
Days to Decision 31 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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