510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953591Substantially Equivalent

Cep 8 Spectrumorange DNA Probe Kit

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

K953591 is the FDA 510(k) clearance record for CEP 8 SPECTRUMORANGE DNA PROBE KIT, a class II device, cleared for Vysis on under FDA product code OYU (Dna-Probe Kit, Human Chromosome). FDA's definition for product code OYU reads: "Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a...". FDA records list 9 510(k) clearances for Vysis, from to . As of , FDA records show no recalls naming K953591.

Clearance record

Decision date
Received
(486 days to decision)
Product code
OYU Dna-Probe Kit, Human Chromosome
Regulation
21 CFR 866.4700
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 OYU

Trailing 12 months

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

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