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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase-esterase, enzymatic, photometric, lipase
510(k) Number K952816
Device Name LIPASE FLEX REAGENT CARTRIDGE
Applicant
DUPONT MEDICAL PRODUCTS
BARLEY MILL PLAZA
P22-1170
WILMINGTON,  DE  19880 -0022
Applicant Contact CAROLYN K GEORGE
Correspondent
DUPONT MEDICAL PRODUCTS
BARLEY MILL PLAZA
P22-1170
WILMINGTON,  DE  19880 -0022
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1465
Classification Product Code
CHI  
Date Received06/20/1995
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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