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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, Phenobarbital
510(k) Number K944932
Device Name PHENOBARBITAL FLEX REAGENT CARTRIDGE
Applicant
Dupont Medical Products
P.O. Box 80022
Barley Mill Plz., P22-1170
Wilmington,  DE  19880
Applicant Contact CAROLYN K GEORGE
Correspondent
Dupont Medical Products
P.O. Box 80022
Barley Mill Plz., P22-1170
Wilmington,  DE  19880
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received10/06/1994
Decision Date 12/28/1994
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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