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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 K883746
Device Name MICROMEDIC FERRITIN IRMA KIT
Applicant
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number866.5340
Classification Product Code
DBF  
Date Received09/01/1988
Decision Date 10/27/1988
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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