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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 K063145
Device Name PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
Applicant
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Correspondent Contact PAIVI SORMUNEN
Regulation Number862.3350
Classification Product Code
DIP  
Subsequent Product Code
DKB  
Date Received10/16/2006
Decision Date 10/17/2007
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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