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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K885176
Device Name AMYLASE SR LIQUID STABLE REAGENT SET
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO,  CA  93012
Applicant Contact L ANDERSON
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO,  CA  93012
Correspondent Contact L ANDERSON
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received12/14/1988
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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