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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic, carbon-dioxide
510(k) Number K061238
Device Name DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1160
Classification Product Code
KHS  
Subsequent Product Codes
CFJ   CGX  
Date Received05/03/2006
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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