510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100015Substantially Equivalent

Vysis Cll Fish Probe Kit (Vysis Lsi Tp53 Spectrumorange/atm Spectrumgreen) and Lsi D135319 Spectrumorange/13q34

Abbott Molecular, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100015 is the FDA 510(k) clearance record for VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34, a class II device, cleared for Abbott Molecular, Inc. 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 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show no recalls naming K100015.

Clearance record

Decision date
Received
(582 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
Abbott Molecular, Inc. 1300 E Touhy Ave., Des Plaines IL
510(k) summary
Summary PDF
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