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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazo colorimetry, bilirubin
510(k) Number K050869
Device Name MODIFICATION TO ABL800 FLEX
Applicant
RADIOMETER MEDICAL APS
1455 PENNSYLVANIA AVENUE N.W.
WILLARD OFFICE BUILDING
WASHINGTON,  DC  20004
Applicant Contact MARK A HELLER
Correspondent
RADIOMETER MEDICAL APS
1455 PENNSYLVANIA AVENUE N.W.
WILLARD OFFICE BUILDING
WASHINGTON,  DC  20004
Correspondent Contact MARK A HELLER
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Codes
CEM   CGA   CGZ   CHL   GHS  
JFP   JGS   KHP   KQI   MQM  
Date Received04/06/2005
Decision Date 08/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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