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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 K832759
Device Name TOTAL IRON-BINDING CAPACITY ACCESORY
Applicant
Seragen Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Seragen Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1415
Classification Product Code
JMO  
Date Received08/19/1983
Decision Date 10/14/1983
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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