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Medical Genetics devices
6 product codes reviewed by the Medical Genetics panel. 17 510(k) clearances and 4 recalls in the FDA data, 50% of those recalls name a 510(k).
1510(k)s in 12 months
2recalls in 12 months
2recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OYX | Bcr/Abl1 Monitoring Test | 2 | 1 | 2 |
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