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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K983759
Device Name ABBOTT ARCHITECT FERRITIN
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Applicant Contact LAURA GRANITZ
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Correspondent Contact LAURA GRANITZ
Regulation Number866.5340
Classification Product Code
DBF  
Date Received10/26/1998
Decision Date 12/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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