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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K040925
Device Name NORMAL AND HYPERGAMMA CONTROL SERUM
Applicant
Sebia
13805 Waterloo
Chelsea,  MI  48118
Applicant Contact BOREK JANIK
Correspondent
Sebia
13805 Waterloo
Chelsea,  MI  48118
Correspondent Contact BOREK JANIK
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/08/2004
Decision Date 04/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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