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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
Device Name ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
Applicant
Microgenics Corporation
46360 FREMONT BLVD.
FREMONT,  CA  94538
Applicant Contact KAREN LEE
Correspondent
Microgenics Corporation
46360 FREMONT BLVD.
FREMONT,  CA  94538
Correspondent Contact KAREN LEE
Regulation Number862.3200
Classification Product Code
DKB  
Date Received03/28/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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