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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 K041793
Device Name OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Applicant Contact BEV HARDING
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Correspondent Contact BEV HARDING
Regulation Number862.1415
Classification Product Code
JMO  
Date Received07/02/2004
Decision Date 07/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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