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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K093441
Device Name DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact FRANCES A DILLON
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact FRANCES A DILLON
Regulation Number862.3320
Classification Product Code
KXT  
Subsequent Product Code
DLJ  
Date Received11/05/2009
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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