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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K943704
Device Name LIPASE CALIBRATOR
Applicant
The DU Pont Co.
Medical Products
Bmp22/1170
Wilmington,  DE  19880
Applicant Contact CAROLYN K GEORGE
Correspondent
The DU Pont Co.
Medical Products
Bmp22/1170
Wilmington,  DE  19880
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/01/1994
Decision Date 09/14/1994
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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