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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Tobramycin
510(k) Number K850058
Device Name DU PONT TOBRAMYCIN ASSAY REAGENTS
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Applicant Contact ROGER C BRIDEN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Correspondent Contact ROGER C BRIDEN
Regulation Number862.3900
Classification Product Code
LCR  
Date Received01/08/1985
Decision Date 01/18/1985
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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