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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, Methotrexate
510(k) Number K884744
Device Name ACA DU PONT METHOTREXATE (MTHO) METHOD
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Correspondent Contact CHRISTOPHER BENTSEN
Classification Product Code
LAO  
Date Received11/14/1988
Decision Date 01/30/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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