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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 K150226
Device Name Hematocrit and Metabolite QUALICHECK
Applicant
Radiometer Medical Aps
Akandevej 21
Bronshoj,  DK
Applicant Contact Mette Skytte Harpsoee
Correspondent
Radiometer Medical Aps
Akandevej 21
Bronshoj,  DK
Correspondent Contact Mette Skytte Harpsoee
Regulation Number862.1660
Classification Product Code
JJS  
Date Received02/02/2015
Decision Date 05/13/2015
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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