510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954214Substantially Equivalent

Cep X Spectrumorange\y Spectrumgreen DNA Probe Kit

Vysis, Downers Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954214 is the FDA 510(k) clearance record for CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT, a class II device, cleared for Vysis on under FDA product code OXP (Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment). FDA's definition for product code OXP reads: "X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to...". FDA records list 9 510(k) clearances for Vysis, from to . As of , FDA records show no recalls naming K954214.

Clearance record

Decision date
Received
(502 days to decision)
Product code
OXP Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Vysis 3100 Woodcreek Dr., Downers Grove IL
510(k) summary
Summary
Third party review
No

Clearances, product code OXP

Trailing 12 months

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

FDA records show no clearances under product code OXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXP, 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