Cleared Traditional

K112143 - AUDIT MICROCV T-UPTAKE LINEARITY
(FDA 510(k) Clearance)

K112143 · Aalto Scientific, Ltd. · Chemistry

Jan 2012

Decision

189d

Days

Class 1

Risk

K112143 is an FDA 510(k) clearance for the AUDIT MICROCV T-UPTAKE LINEARITY, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on January 31, 2012, 189 days after receiving the submission on July 26, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K112143 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2011
Decision Date	January 31, 2012
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF