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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 K994115
Device Name TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ROBIN O NORRIS
Correspondent
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ROBIN O NORRIS
Regulation Number862.1415
Classification Product Code
JMO  
Date Received12/06/1999
Decision Date 01/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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