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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 K120326
Device Name AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
Original Applicant
RADIOMETER MEDICAL APS
akandevej 21
bronshoj,  DK dk-2700
Original Contact ole schou
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
JIT   JJY  
Date Received02/02/2012
Decision Date 11/21/2012
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
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