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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
510(k) Number K946328
Device Name TDX(R)/TDXFLX(R) PHENYTOIN II
Applicant
Abbott Laboratories
One Abbott Park Rd.
D389, Ap30
Abbott Park,  IL  60064
Applicant Contact DOUG KENTZ
Correspondent
Abbott Laboratories
One Abbott Park Rd.
D389, Ap30
Abbott Park,  IL  60064
Correspondent Contact DOUG KENTZ
Regulation Number862.3350
Classification Product Code
LGR  
Date Received12/29/1994
Decision Date 03/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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