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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K103403
Model 1E65-05
Device Name MULTICONSTITUENT CALIBRATOR
Original Applicant
ABBOTT LABORATORIES
1921 hurd drive
irving,  TX  75038 4396
Original Contact linda morris
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/19/2010
Decision Date 02/04/2011
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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