Xpert Carba-R
FDA 510(k) clearance K173263 · decided 2018-01-09
Clearance details
- K-number
- K173263
- Device name
- Xpert Carba-R
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2017-10-11
- Decision date
- 2018-01-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- POC
- Device class
- 2
- Regulation number
- 866.1640
- 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 Carba-R (K261867) | Cepheid® | 2026-07-02 |
| BD MAX Check-Points CPO (K190613) | Check-Points Health B.V. | 2019-08-29 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
Recalls involving this device
No recalls on record reference this clearance.