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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Ferritin, Antigen, Antiserum, Control
510(k) Number K882822
Device Name FIAGEN FERRITIN
Applicant
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Applicant Contact JAMES CLELLAND
Correspondent
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Correspondent Contact JAMES CLELLAND
Regulation Number866.5550
Classification Product Code
DFL  
Date Received07/08/1988
Decision Date 08/04/1988
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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