Cleared Traditional

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

K163462 · Radiometer Medical Aps · Chemistry
Sep 2017
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K163462 is an FDA 510(k) clearance for the AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Radiometer Medical Aps (Dk-Bronshoj, DK). The FDA issued a Cleared decision on September 21, 2017, 286 days after receiving the submission on December 9, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K163462 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2016
Decision Date September 21, 2017
Days to Decision 286 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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