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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 K123372
Model LN-5P56-01
Device Name ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Original Applicant
ABBOTT LABORATORIES
1921 hurd dr.
irving,  TX  75038
Original Contact linda morris
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/04/2012
Decision Date 01/14/2013
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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