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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 K990216
Device Name MAGNETIC TIBC KIT
Applicant
Reference Diagnostics, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Applicant Contact JOSEPH LAWLOR
Correspondent
Reference Diagnostics, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact JOSEPH LAWLOR
Regulation Number862.1415
Classification Product Code
JMO  
Date Received01/22/1999
Decision Date 02/16/1999
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
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