Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
FDA 510(k) clearance K171552 · decided 2017-12-19
Clearance details
- K-number
- K171552
- Device name
- Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2017-05-26
- Decision date
- 2017-12-19
- Days to decision
- 207 days
- Clearance type
- Dual Track
- Product code
- OCC
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.