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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 K130236
Device Name RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
Applicant
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact Martin Gabler
Correspondent
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact Martin Gabler
Regulation Number862.1660
Classification Product Code
JJS  
Date Received01/30/2013
Decision Date 03/15/2013
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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