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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, microarray-based, genome-wide, postnatal chromosomal abnormality detection
510(k) Number K163367
Device Name GenetiSure Dx Postnatal Assay
Applicant
Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara,  CA  95051
Applicant Contact Lois Nakayama
Correspondent
Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara,  CA  95051
Correspondent Contact Bill Kurani
Regulation Number866.5920
Classification Product Code
PFX  
Date Received11/30/2016
Decision Date 08/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Molecular Genetics
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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