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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K163462
Device Name AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
Applicant
Radiometer Medical Aps
Aakandevej 21
Dk-Bronshoj,  DK 2700
Applicant Contact Per Pape Thomsen
Correspondent
Radiometer Medical Aps
Aakandevej 21
Dk-Bronshoj,  DK 2700
Correspondent Contact Per Pape Thomsen
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
DDR   KHO  
Date Received12/09/2016
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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