Cleared Traditional

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

K111964 · Aalto Scientific, Ltd. · Chemistry
Mar 2012
Decision
235d
Days
Class 1
Risk

About This 510(k) Submission

K111964 is an FDA 510(k) clearance for the AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY, 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 March 2, 2012, 235 days after receiving the submission on July 11, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K111964 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2011
Decision Date March 02, 2012
Days to Decision 235 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJY Multi-analyte Controls, All Kinds (assayed)

All 672
Multichem IA Plus
K162530 · Techno-Path Manufacturing · Mar 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · Aalto Scientific, Ltd. · Mar 2017
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · Bio-Rad Laboratories · Jan 2017
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
K153712 · Radiometer America, Inc. · Jan 2016
Liquichek Cardiac Markers Plus Control LT
K150300 · Bio-Rad Laboratories · Dec 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · Maine Standards Company, LLC · Apr 2015