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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K884170
Device Name ANALYST THEOPHYLLINE CALIBRATOR
Applicant
The DU Pont Co.
Chestnut Run Plaza
P.O. Box 80715
Wilmington,  DE 
Applicant Contact RICHARD M VAUGHT
Correspondent
The DU Pont Co.
Chestnut Run Plaza
P.O. Box 80715
Wilmington,  DE 
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received09/21/1988
Decision Date 11/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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