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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K861602
Device Name TOTAL IRON BINDING CAPACITY PROCEDURE
Applicant
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Applicant Contact JERRY A GRAHAM
Correspondent
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
ARLINGTON,  TX  76011
Correspondent Contact JERRY A GRAHAM
Regulation Number862.1410
Classification Product Code
CFM  
Date Received04/29/1986
Decision Date 05/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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