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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K063150
Device Name COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
Applicant
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Correspondent Contact PAIVI SORMUNEN
Regulation Number866.5240
Classification Product Code
CZW  
Subsequent Product Codes
DBI   JIX   JJY  
Date Received10/16/2006
Decision Date 03/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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