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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 K880743
Device Name ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Applicant Contact BARBARA BOOKER
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Correspondent Contact BARBARA BOOKER
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/24/1988
Decision Date 04/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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