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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complete Gene Expression Profiling Accessory Reagents
510(k) Number K103112
Device Name AFFYMETRIX GENE PROFILING REAGENTS
Applicant
Affymetrix, Inc.
3 Lagoon Dr.
Suite 160
Redwood Shores,  CA  94065
Applicant Contact MAUREEN MENDE
Correspondent
Affymetrix, Inc.
3 Lagoon Dr.
Suite 160
Redwood Shores,  CA  94065
Correspondent Contact MAUREEN MENDE
Regulation Number862.2570
Classification Product Code
OVA  
Date Received10/21/2010
Decision Date 05/04/2011
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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