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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 K101809
Device Name FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Applicant Contact STACEY DOLAN
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Correspondent Contact STACEY DOLAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/29/2010
Decision Date 10/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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