Cleared Traditional

K101427 - AUDIT MICROCV HS-CRP LINEARITY SET
(FDA 510(k) Clearance)

K101427 · Aalto Scientific, Ltd. · Chemistry

Dec 2010

Decision

216d

Days

Class 1

Risk

K101427 is an FDA 510(k) clearance for the AUDIT MICROCV HS-CRP LINEARITY SET, 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 December 23, 2010, 216 days after receiving the submission on May 21, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K101427 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2010
Decision Date	December 23, 2010
Days to Decision	216 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF