510(k) K163367

Device: GenetiSure Dx Postnatal Assay
Applicant: Agilent Technologies, Inc.
510(k) number: K163367
Product code: PFX
Decision: Substantially Equivalent (SESE)
Decision date: 2017-08-11
Date received: 2016-11-30
Regulation: 866.5920
Classification name: System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection
Medical specialty: Immunology
Review panel: Molecular Genetics
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05700571112618	GenetiSure Dx Labeling Kit Purification Columns	AGILENT TECHNOLOGIES, INC.	2017-11-08
05700571112656	GenetiSure Dx Cot-1 Human DNA	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112649	GenetiSure Dx Wash Buffer 2	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112632	GenetiSure Dx Wash Buffer 1	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112625	GenetiSure Dx Hybridization Kit	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112601	GenetiSure Dx Labeling Kit	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571108697	GenetiSure Dx Postnatal Assay	AGILENT TECHNOLOGIES, INC.	2017-11-07

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN130018	CYTOSCAN(R) DX	Affymetrix, Inc.	2014-01-17

summary

Decision Summary