PDO — Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization Class II
FDA product code PDO covers "Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization", a Class II medical device regulated under 21 CFR 864.1870. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PDO
- Device Class
- Class II
- Regulation Number
- 864.1870
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130010 | abbott molecular | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | July 29, 2013 |