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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 K883104
Device Name CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact LEONARD DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact LEONARD DWARICA
Regulation Number862.1415
Classification Product Code
JMO  
Date Received07/25/1988
Decision Date 10/25/1988
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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