FDA product code OWK: Early Growth Response 1 (Egr) Fish Probe Kit
OWK is the FDA product code for early growth response 1 (egr) fish probe kit. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under OWK. The average 510(k) review took 789 days (median 789).
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.
Classification
| Field | Value |
|---|---|
| Device name | Early Growth Response 1 (Egr) Fish Probe Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.6040 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OWK clearance
Top OWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 2011-08-29 |
Most recent OWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091960 | Abbott Molecular, Inc. | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 | 2011-08-29 | 789 |
Recalls for OWK devices
openFDA lists no recalls for product code OWK.
Frequently asked questions
What is FDA product code OWK?
OWK is the FDA product code for early growth response 1 (egr) fish probe kit. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel.
What device class is OWK?
Class II, regulation 21 CFR 866.6040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWK?
Across 1 cleared submissions the average was 789 days from receipt to decision (median 789).
Which companies have the most OWK clearances?
Abbott Molecular, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWK
- Run a recall and safety report across every OWK manufacturer
- Watch product code OWK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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