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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 K061703
Device Name DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/16/2006
Decision Date 08/02/2006
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
Recalls CDRH Recalls
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