510(k) DEN160003
- Device
- Quantidex qPCR BCR-ABL IS Kit
- Applicant
- Asuragen, Inc.
- 510(k) number
- DEN160003
- Product code
- OYX
- Decision
- Unknown (DENG)
- Decision date
- 2016-07-22
- Date received
- 2016-01-19
- Regulation
- 866.6060
- Classification name
- Bcr/Abl1 Monitoring Test
- Medical specialty
- Medical Genetics
- Review panel
- Medical Genetics
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- FAYYAZ MEMON
- Address
- 2150 Woodward, Suite 100 Austin TX US 78744 78744
FDA Registration Numbers#
- 1550222
- 3021269066
- 3003436513
- 2915274
- 3016838963
- 3007125666
- 3004530258
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | 2017-12-22 |