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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name olive oil emulsion (turbidimetric), lipase
510(k) Number K901858
Device Name MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
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
Regulation Number862.1465
Classification Product Code
CET  
Date Received04/24/1990
Decision Date 06/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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