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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, Centrifugal, For Clinical Use
510(k) Number K854523
Device Name ANALYST PHYSICIAN'S OFFICE PROFILER
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact ROGER C BRIDEN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact ROGER C BRIDEN
Regulation Number862.2140
Classification Product Code
JJG  
Date Received11/12/1985
Decision Date 01/08/1986
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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