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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiometric, Fe59, Iron Binding Capacity
510(k) Number K800868
Device Name FERRO-QUANT TM FE 59 TEST KIT
Applicant
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1415
Classification Product Code
JQG  
Date Received04/17/1980
Decision Date 04/29/1980
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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