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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 K942424
Device Name DMA MICROPROTEIN PROCEDURE
Applicant
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Applicant Contact REGULATORY AFFAIRS PERSON
Correspondent
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Correspondent Contact REGULATORY AFFAIRS PERSON
Regulation Number862.1635
Classification Product Code
CEK  
Date Received05/20/1994
Decision Date 09/06/1994
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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