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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Theophylline
510(k) Number K884002
Device Name ANALYST THEOPHYLLINE ROTOR
Applicant
The DU Pont Co.
Chestnut Run Plaza
P.O. Box 80715
Wilmington,  DE 
Applicant Contact M VAUGHT
Correspondent
The DU Pont Co.
Chestnut Run Plaza
P.O. Box 80715
Wilmington,  DE 
Correspondent Contact M VAUGHT
Regulation Number862.3880
Classification Product Code
KLS  
Date Received09/21/1988
Decision Date 10/31/1988
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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