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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Olive Oil Emulsion (Turbidimetric), Lipase
510(k) Number K862440
Device Name PARAMAX LIPASE REAGENT
Applicant
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact KRISTA L UNDERWOOD
Correspondent
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact KRISTA L UNDERWOOD
Regulation Number862.1465
Classification Product Code
CET  
Date Received06/26/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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