Cleared Traditional

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

K112161 · Radiometer Medical Aps · Chemistry

Jan 2012

Decision

177d

Days

Class 1

Risk

About This 510(k) Submission

K112161 is an FDA 510(k) clearance for the AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.., a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on January 20, 2012, 177 days after receiving the submission on July 27, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number	K112161 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2011
Decision Date	January 20, 2012
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF