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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrators, drug specific
510(k) Number K831209
Device Name GENTAMICIN CALIBRATOR -ACA
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received04/14/1983
Decision Date 05/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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