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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name instrumentation for clinical multiplex test systems
De Novo Number DEN040012
510(K) Number K042279
Device Name AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
Requester
affymetrix, inc.
3380 central expressway
santa clara,  CA  95051
Contact robert lipshutz
Regulation Number862.2570
Classification Product Code
NSU  
Date Received11/03/2004
Decision Date 12/23/2004
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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