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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Ferritin, Antigen, Antiserum, Control
510(k) Number K881345
Device Name IMX FERRITIN
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MATT KLAMRZYNSKI
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number866.5510
Classification Product Code
DGD  
Date Received03/30/1988
Decision Date 05/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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