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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K862359
Device Name METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number862.1110
Classification Product Code
CIG  
Date Received06/23/1986
Decision Date 08/19/1986
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
Recalls CDRH Recalls
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