Cleared Traditional

K130762 - AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
(FDA 510(k) Clearance)

K130762 · Aalto Scientific, Ltd. · Chemistry

Apr 2013

Decision

40d

Days

Class 1

Risk

K130762 is an FDA 510(k) clearance for the AUDIT MICROCV THERAPEUTIC DRUG (TDM) 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 April 29, 2013, 40 days after receiving the submission on March 20, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K130762 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2013
Decision Date	April 29, 2013
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF