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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K130415
Device Name HIGH METABOLITE QUALICHECK
Applicant
Radiometer Medical Aps
Aakandevej 21
Broenshoej,  DK DK-2700
Applicant Contact Martin Gabler
Correspondent
Radiometer Medical Aps
Aakandevej 21
Broenshoej,  DK DK-2700
Correspondent Contact Martin Gabler
Regulation Number862.1660
Classification Product Code
JJS  
Date Received02/19/2013
Decision Date 03/26/2013
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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