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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K890317
Device Name TOTAL PROTEIN REAGENT
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 Number862.1635
Classification Product Code
CEK  
Date Received01/23/1989
Decision Date 03/08/1989
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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