510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K091960Substantially Equivalent

Vysis Egr1 Fish Probe Kit (Vysis Lsi Egr1 Spectrum/orange/d5s23, D5s721, Spectrum Green Probe), Model 4N37-020

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

K091960 is the FDA 510(k) clearance record for VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020, a class II device, cleared for Abbott Molecular, Inc. on under FDA product code OWK (Early Growth Response 1 (Egr) Fish Probe Kit). FDA's definition for product code OWK reads: "The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of...". FDA records list 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show no recalls naming K091960.

Clearance record

Decision date
Received
(789 days to decision)
Product code
OWK Early Growth Response 1 (Egr) 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 OWK

Trailing 12 months

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

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