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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 K885078
Device Name LIPASE SR LIQUID STABLE REAGENT SET
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO,  CA  93012
Applicant Contact DONNA L ANDERSON
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO,  CA  93012
Correspondent Contact DONNA L ANDERSON
Regulation Number862.1465
Classification Product Code
CET  
Date Received12/08/1988
Decision Date 03/13/1989
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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