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.

Leading manufacturers include Abbott Molecular, Inc..

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
Cleared Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
K091960
Abbott Molecular, Inc.
Pathology · 789d

About Product Code OWK - Regulatory Context