510(k) K190076
- Device
- Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems
- Applicant
- Cepheid
- 510(k) number
- K190076
- Product code
- OYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-27
- Date received
- 2019-01-16
- 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
- Yi-Ping Lin
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
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 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | 2017-12-22 |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Asuragen, Inc. | 2016-07-22 |
Legacy Summary#
summary
FDA Review#
Decision Summary