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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K092686
Device Name ABL90 FLEX SERIES
Applicant
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Applicant Contact LONE RONNEMOES PEDERSEN
Correspondent
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Correspondent Contact LONE RONNEMOES PEDERSEN
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGA   CGZ   CHL   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
Date Received09/02/2009
Decision Date 08/06/2010
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
Recalls CDRH Recalls
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