510(k) DEN070004
- Device
- XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
- Applicant
- Cepheid
- 510(k) number
- DEN070004
- Product code
- OAI
- Decision
- Unknown (DENG)
- Decision date
- 2007-03-16
- Date received
- 2007-03-12
- Regulation
- 866.3225
- Classification name
- Assay, Enterovirus Nucleic Acid
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- RUSSEL K ENNS, PH.D.
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3004530258
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OAI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K063261 | NUCLISENS EASYQ ENTEROVIRUS SYSTEM | bioMerieux, Inc. | 2008-06-23 |