Cleared Traditional

Audit MicroControls Linearity LQ Cystatin-C

K143571 · Aalto Scientific, Ltd. · Chemistry
Jan 2015
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K143571 is an FDA 510(k) clearance for the Audit MicroControls Linearity LQ Cystatin-C, 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 23, 2015, 37 days after receiving the submission on December 17, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K143571 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2014
Decision Date January 23, 2015
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 492
Beta-CrossLaps CalCheck 5
K170678 · Roche Diagnostics · Apr 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · Roche Diagnostics · Jan 2017
Multichem A1c
K162514 · Technopath Manufacturing · Oct 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · Aalto Scientific, Ltd. · Aug 2016
LIAISON EBV IgM Serum Control Set
K161522 · DiaSorin, Inc. · Jun 2016
LIAISON CMV IgM Serum Control Set
K161526 · DiaSorin, Inc. · Jun 2016