Product code OWK— Immunology
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
- Classification name
- Early Growth Response 1 (Egr) Fish Probe Kit
- Device class
- Class 2
- Regulation
- 21 CFR 866.6040
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code OWK
FDA has cleared device under product code OWK, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code OWK
Recent clearances under product code OWK
Data sourced from openFDA. This site is unofficial and independent of the FDA.