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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, Diphenylhydantoin
510(k) Number K080696
Device Name ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact CAROL JOCHUM
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact CAROL JOCHUM
Regulation Number862.3350
Classification Product Code
DIP  
Subsequent Product Code
LGR  
Date Received03/12/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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