Cleared Traditional

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

K082717 · Aalto Scientific, Ltd. · Immunology
Oct 2008
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K082717 is an FDA 510(k) clearance for the AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5, 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 October 30, 2008, 43 days after receiving the submission on September 17, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K082717 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2008
Decision Date October 30, 2008
Days to Decision 43 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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