Cleared Traditional

AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

K112705 · Aalto Scientific, Ltd. · Immunology
Jan 2012
Decision
130d
Days
Class 1
Risk

About This 510(k) Submission

K112705 is an FDA 510(k) clearance for the AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL, 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 24, 2012, 130 days after receiving the submission on September 16, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K112705 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2011
Decision Date January 24, 2012
Days to Decision 130 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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