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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K863840
Device Name METH. & CALI. FOR THE DIMENSION CLINI/CHEM. 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 Number862.2160
Classification Product Code
JJE  
Date Received10/01/1986
Decision Date 11/05/1986
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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