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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, Digitoxin
510(k) Number K062024
Device Name DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.3300
Classification Product Code
LFM  
Subsequent Product Codes
DIP   KLS   KXT   LAN   LCD  
Date Received07/18/2006
Decision Date 07/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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