510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962873Substantially Equivalent

Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration DNA Probe

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

K962873 is the FDA 510(k) clearance record for CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE, a class II device, cleared for Vysis on under FDA product code OVQ (Chronic Lymphocytic Leukemia Fish Probe Kit). FDA's definition for product code OVQ reads: "The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia...". FDA records list 9 510(k) clearances for Vysis, from to . As of , FDA records show no recalls naming K962873.

Clearance record

Decision date
Received
(174 days to decision)
Product code
OVQ Chronic Lymphocytic Leukemia Fish Probe Kit
Regulation
21 CFR 866.6040
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 OVQ

Trailing 12 months

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

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