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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 K983133
Device Name TBIL
Applicant
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIX  
Date Received09/08/1998
Decision Date 09/16/1998
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
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