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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 K121985
Device Name ARCHITECT TOTAL BILIRUBIN
Original Applicant
ABBOTT LABORATORIES
1921 hurd drive
irving,  TX  75038
Original Contact linda morris
Regulation Number862.1110
Classification Product Code
CIG  
Date Received07/06/2012
Decision Date 02/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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