Cleared Traditional

Audit MicroControls Linearity FD Tumor Markers II

K143573 · Aalto Scientific, Ltd. · Immunology
Jan 2015
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K143573 is an FDA 510(k) clearance for the Audit MicroControls Linearity FD Tumor Markers II, 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 January 16, 2015, 30 days after receiving the submission on December 17, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K143573 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2014
Decision Date January 16, 2015
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
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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