510(k) K173492
- Device
- MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
- Applicant
- MolecularMD Corporation
- 510(k) number
- K173492
- Product code
- OYX
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 2017-12-22
- Date received
- 2017-11-13
- Regulation
- 866.6060
- Classification name
- Bcr/abl1 Monitoring Test
- Medical specialty
- Molecular Genetics
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Hawkins
- Address
- 1341 SW Custer Dr. Portland OR US 97219 97219
FDA Registration Numbers#
- 1550222
- 3021269066
- 3003436513
- 2915274
- 3016838963
- 3007125666
- 3004530258
Source Documents#
Other 510(k) Records For Product Code OYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | 2019-09-27 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Asuragen, Inc. | 2016-07-22 |
Legacy Summary#
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FDA Review#
Decision Summary