PDO · Class II · 21 CFR 864.1870

FDA Product Code PDO: Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization

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.

1
Total
0
Cleared
111d
Avg days
2013
Since

FDA 510(k) Cleared Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization Devices (Product Code PDO)

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About Product Code PDO - Regulatory Context