510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163367Substantially Equivalent

GenetiSure Dx Postnatal Assay

Agilent Technologies, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163367 is the FDA 510(k) clearance record for GenetiSure Dx Postnatal Assay, a class II device, cleared for Agilent Technologies, Inc. on under FDA product code PFX (System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection). FDA's definition for product code PFX reads: "A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is...". FDA records list 51 510(k) clearances for Agilent Technologies, Inc., from to . As of , FDA records show one recall naming K163367.

Clearance record

Decision date
Received
(254 days to decision)
Product code
PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Regulation
21 CFR 866.5920
Device class
Class II
Review panel
Immunology
Applicant
Agilent Technologies, Inc. 5301 Stevens Creek Blvd., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFX

Trailing 12 months

FDA records hold no clearances under product code PFX in the trailing twelve months.

FDA records show no clearances under product code PFX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260