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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K914508
Device Name DIMENSION(R) LACTIC ACID METHOD
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Applicant Contact ROBERT B TAYLOR
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Correspondent Contact ROBERT B TAYLOR
Regulation Number862.1450
Classification Product Code
KHP  
Date Received10/09/1991
Decision Date 11/27/1991
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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