OWKClass II

Early Growth Response 1 (Egr) Fish Probe Kit

21 CFR 866.6040 / Immunology

OWK is the FDA product code for Early Growth Response 1 (Egr) Fish Probe Kit, a class II device type, regulated under 21 CFR 866.6040. FDA's definition for this code 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 diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml)...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2011-08-29, and no recalls.

Classification record

Product code: OWK
Device name: Early Growth Response 1 (Egr) Fish Probe Kit
FDA definition: 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 diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.
Regulation: 21 CFR 866.6040
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OWK

By decision year

1 clearance under product code OWK with a decision year between 2011 and 2011, 2011 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OWK by decision year
Year	Clearances
2011	1

Applicants with the most clearances

Product code OWK

Applicants holding the most 510(k) clearances under product code OWK
Applicant	Clearances
Abbott Molecular, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Abbott Molecular, Inc.

Recent clearances

Product code OWK

K091960Class IIVysis Egr1 Fish Probe Kit (Vysis Lsi Egr1 Spectrum/orange/d5s23, D5s721, Spectrum Green Probe), Model 4N37-020Abbott Molecular, Inc. / cleared 2011-08-29

Recent recalls

Product code OWK

FDA records show no recalls under product code OWK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)