FDA product code PDO: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
PDO is the FDA product code for early growth response gene 1 (egr1) fish probe kit for specimen characterization. It is a Class II device, regulated under 21 CFR 864.1870 and reviewed by the Pathology panel. Devices under PDO reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization |
| Device class | Class II |
| Regulation | 21 CFR 864.1870 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PDO devices
openFDA lists no recalls for product code PDO.
Frequently asked questions
What is FDA product code PDO?
PDO is the FDA product code for early growth response gene 1 (egr1) fish probe kit for specimen characterization. It is a Class II device, regulated under 21 CFR 864.1870 and reviewed by the Pathology panel.
What device class is PDO?
Class II, regulation 21 CFR 864.1870. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PDO
- Run a recall and safety report across every PDO manufacturer
- Watch product code PDO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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