Cleared Traditional

K101216 - AUDIT MICROCV PROTEIN LINEARITY SET
(FDA 510(k) Clearance)

K101216 · Aalto Scientific, Ltd. · Chemistry

Jan 2011

Decision

259d

Days

Class 1

Risk

K101216 is an FDA 510(k) clearance for the AUDIT MICROCV PROTEIN 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 14, 2011, 259 days after receiving the submission on April 30, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K101216 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2010
Decision Date	January 14, 2011
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF