Cleared Traditional

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

K120326 · Radiometer Medical Aps · Chemistry
Nov 2012
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K120326 is an FDA 510(k) clearance for the AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on November 21, 2012, 293 days after receiving the submission on February 2, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K120326 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2012
Decision Date November 21, 2012
Days to Decision 293 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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