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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 K080995
Device Name MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
Applicant
Affymetrix, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Applicant Contact MAUREEN J MENDE
Correspondent
Affymetrix, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Correspondent Contact MAUREEN J MENDE
Regulation Number862.2570
Classification Product Code
NSU  
Date Received04/07/2008
Decision Date 07/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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