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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
510(k) Number K864548
Device Name ALFERR TIBC TUBE
Applicant
Benchmark Reagents
74 Baillie St.
Horsham 3400, Victoria
Australia,  AU
Applicant Contact STARR
Correspondent
Benchmark Reagents
74 Baillie St.
Horsham 3400, Victoria
Australia,  AU
Correspondent Contact STARR
Regulation Number862.1415
Classification Product Code
JQE  
Date Received11/19/1986
Decision Date 02/02/1987
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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