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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 K022339
Device Name TOTAL BILIRUBIN
Applicant
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Applicant Contact MICHELE SMITH-WAHEED
Correspondent
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Correspondent Contact MICHELE SMITH-WAHEED
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIT  
Date Received07/18/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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