XPERT MTB/RIF ASSAY
FDA 510(k) clearance DEN130032 · decided 2013-07-25
Clearance details
- K-number
- DEN130032
- Device name
- XPERT MTB/RIF ASSAY
- Applicant
- Cepheid
- Decision
- Unknown
- Date received
- 2013-06-11
- Decision date
- 2013-07-25
- Days to decision
- 44 days
- Clearance type
- Direct
- Product code
- PEU
- Device class
- 2
- Regulation number
- 866.3373
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (K143302) | Cepheid | 2015-02-12 |
Recalls involving this device
No recalls on record reference this clearance.