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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
510(k) Number K842019
Device Name TIBC PRETREATMENT KIT
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 Number862.1415
Classification Product Code
JQE  
Date Received05/18/1984
Decision Date 06/22/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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