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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Thymolphthale Inmonophosphate
510(k) Number K864230
Device Name DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number862.1020
Classification Product Code
CKE  
Date Received10/28/1986
Decision Date 11/28/1986
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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