FDA 510(k) Applications for Medical Device Product Code "OYX"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| DEN160003 | ASURAGEN, INC. | Quantidex qPCR BCR-ABL IS Kit | 07/22/2016 |
| K181661 | Bio-Rad Laboratories, Inc. | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | 02/13/2019 |
| K190076 | Cepheid | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | 09/27/2019 |
| K173492 | MolecularMD Corporation | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | 12/22/2017 |
| K221869 | Suzhou Sniper Medical Technologies Co., Ltd | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | 09/05/2023 |
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