Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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.
Carpinteria,  CA  95051
Applicant Contact Lois Nakayama
Correspondent
Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Carpinteria,  CA  95051
Correspondent Contact Bill Kurani
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-