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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number K093128
Device Name ILLUMINA BEADXPRESS SYSTEM
Applicant
ILLUMINA, INC.
5200 ILLUMINA WAY
SAN DIEGO,  CA  92122
Applicant Contact DONALD R ELLIS
Correspondent
ILLUMINA, INC.
5200 ILLUMINA WAY
SAN DIEGO,  CA  92122
Correspondent Contact DONALD R ELLIS
Regulation Number862.2570
Classification Product Code
NSU  
Date Received10/02/2009
Decision Date 04/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00959504
Reviewed by Third Party No
Combination Product No
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