QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k) clearance K181661 · decided 2019-02-13
Clearance details
- K-number
- K181661
- Device name
- QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-25
- Decision date
- 2019-02-13
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- OYX
- Device class
- 2
- Regulation number
- 866.6060
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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| Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (K252243) | Suzhou Precigenome, Ltd. Co; | 2026-07-02 |
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| MRDx BCR-ABL Test, MRDx BCR-ABL Test Software (K173492) | Molecularmd Corporation | 2017-12-22 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit recall (Z-1358-2024) | Bio-Rad Laboratories | 2024-03-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |