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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 K863258
Device Name TOTAL PROTEIN PROCEDURE
Applicant
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Applicant Contact MARJORIE B POTTS
Correspondent
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Correspondent Contact MARJORIE B POTTS
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/25/1986
Decision Date 09/29/1986
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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