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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K170882
Device Name ABL90 FLEX, ABL90 FLEX PLUS
Applicant
Radiometer Medical Aps
Aakandevej 21
Broenshoej,  DK DK-2700
Applicant Contact Soren Boegestrand
Correspondent
Radiometer Medical Aps
Aakandevej 21
Broenshoej,  DK DK-2700
Correspondent Contact Soren Bogestrand
Regulation Number862.1113
Classification Product Code
MQM  
Date Received03/24/2017
Decision Date 04/28/2017
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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