XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
FDA 510(k) clearance DEN070004 · decided 2007-03-16
Clearance details
- K-number
- DEN070004
- Device name
- XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
- Applicant
- Cepheid
- Decision
- Unknown
- Date received
- 2007-03-12
- Decision date
- 2007-03-16
- Days to decision
- 4 days
- Clearance type
- Post-NSE
- Product code
- OAI
- Device class
- 2
- Regulation number
- 866.3225
- 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 |
|---|---|---|
| NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261) | bioMerieux, Inc. | 2008-06-23 |
Recalls involving this device
No recalls on record reference this clearance.