XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065— 510(k) DEN070004
UnknownCepheid
FDA 510(k) clearance DEN070004 for XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065, Unknown on 2007-03-16. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code OAI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3225
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Post-NSE
- Location
- Sunnyvale, CA, US
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