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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K061655
Device Name DIMENSION VISTA FLEX REAGENT CARTRIDGES
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg.500 M.S. 514; P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg.500 M.S. 514; P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.3030
Classification Product Code
LDP  
Subsequent Product Codes
CDT   CEO   CFR   CHH   DIH  
DKJ   JFJ   JGJ   JHS   JQB   KLI  
KLR   KNK   LAR   LBS   LCR   LEG  
LEH   MRR  
Date Received06/13/2006
Decision Date 07/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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