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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 PARKWAY
MALVERN,  PA  19355 -1307
Applicant Contact STACEY DOLAN
Correspondent
FUJIREBIO DIAGNOSTICS, INC
201 GREAT VALLEY PARKWAY
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
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