Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k) clearance K190076 · decided 2019-09-27
Clearance details
- K-number
- K190076
- Device name
- Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2019-01-16
- Decision date
- 2019-09-27
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- OYX
- Device class
- 2
- Regulation number
- 866.6060
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 recall (Z-0959-2026) | Cepheid | 2025-12-18 |