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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K843202
Device Name HEPARIN CALIBRATOR ACA
Applicant
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact ROGER C BRIDEN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact ROGER C BRIDEN
Regulation Number864.7525
Classification Product Code
KFF  
Date Received08/14/1984
Decision Date 11/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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