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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 system, microarray-based, genome-wide, postnatal chromosomal abnormality detection
De Novo Number DEN130018
510(K) Number K130313
Device Name CYTOSCAN(R) DX
Affymetrix, Inc.
3420 central expressway
santa clara,  CA  95051
Contact eric fung
Regulation Number866.5920
Classification Product Code
Date Received12/18/2013
Decision Date 01/17/2014
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE