MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
FDA 510(k) clearance K173492 · decided 2017-12-22
Clearance details
- K-number
- K173492
- Device name
- MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
- Applicant
- Molecularmd Corporation
- Decision
- Unknown
- Date received
- 2017-11-13
- Decision date
- 2017-12-22
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- OYX
- Device class
- 2
- Regulation number
- 866.6060
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (K252243) | Suzhou Precigenome, Ltd. Co; | 2026-07-02 |
| BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (K221869) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 |
| Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076) | Cepheid | 2019-09-27 |
| QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661) | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| Quantidex qPCR BCR-ABL IS Kit (DEN160003) | Asuragen, Inc. | 2016-07-22 |
Recalls involving this device
No recalls on record reference this clearance.