Cleared Traditional

Audit MicroControls Linearity FD Tumor Markers II

K163629 · Aalto Scientific, Ltd. · Immunology
Mar 2017
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K163629 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. (Eatonton, US). The FDA issued a Cleared decision on March 10, 2017, 78 days after receiving the submission on December 22, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K163629 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2016
Decision Date March 10, 2017
Days to Decision 78 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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