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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferrozine (Colorimetric) Iron Binding Capacity
510(k) Number K881761
Device Name UNSATURATED IRON BINDING CAPACITY
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 Number862.1415
Classification Product Code
JMO  
Date Received04/25/1988
Decision Date 07/08/1988
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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