PDOClass II

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

21 CFR 864.1870 / Hematology

PDO is the FDA product code for Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization, a class II device type, regulated under 21 CFR 864.1870. FDA's definition for this code reads: "The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2013-07-29, and no recalls.

Classification record

Product code: PDO
Device name: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
FDA definition: The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.
Regulation: 21 CFR 864.1870
Device class: Class II
Review panel: Hematology
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 PDO

By decision year

1 clearance under product code PDO with a decision year between 2013 and 2013, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PDO by decision year
Year	Clearances
2013	1

Applicants with the most clearances

Product code PDO

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

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PDO

DEN130010Class IIVysis Egr1 Fish Probe Kit - Sc (Specimen Characterization)Abbott Molecular, Inc. / cleared 2013-07-29

Recent recalls

Product code PDO

FDA records show no recalls under product code PDO.

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)