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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrators, drug mixture
510(k) Number K120936
Model 5P04,
Device Name ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
Original Applicant
MICROGENICS CORPORATION
46360 fremont blvd.
fremont,  CA  94538
Original Contact karen lee
Regulation Number862.3200
Classification Product Code
DKB  
Date Received03/28/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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