FilmArray Respiratory Panel 2 plus (RP2plus)
FDA 510(k) clearance DEN170017 · decided 2017-11-24
Clearance details
- K-number
- DEN170017
- Device name
- FilmArray Respiratory Panel 2 plus (RP2plus)
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Unknown
- Date received
- 2017-03-16
- Decision date
- 2017-11-24
- Days to decision
- 253 days
- Clearance type
- Direct
- Product code
- PZF
- Device class
- 2
- Regulation number
- 866.4001
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.