OWK · Class II · 21 CFR 866.6040

FDA Product Code OWK: Early Growth Response 1 (egr) Fish Probe Kit

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.

1
Total
1
Cleared
789d
Avg days
2011
Since

FDA 510(k) Cleared Early Growth Response 1 (egr) Fish Probe Kit Devices (Product Code OWK)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OWK - Regulatory Context