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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
Device Name MULTICONSTITUENT CALIBRATOR
Applicant
ABBOTT LABORATORIES
1921 HURD DRIVE
IRVING,  TX  75038 -4396
Applicant Contact LINDA MORRIS
Correspondent
ABBOTT LABORATORIES
1921 HURD DRIVE
IRVING,  TX  75038 -4396
Correspondent Contact LINDA MORRIS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/19/2010
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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