Cleared Traditional

AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

K102617 · Aalto Scientific, Ltd. · Chemistry
Jan 2011
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K102617 is an FDA 510(k) clearance for the AUDIT MICROCV CARDIAC MARKERS LINEARITY SET, 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 10, 2011, 122 days after receiving the submission on September 10, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K102617 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2010
Decision Date January 10, 2011
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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