JBAIDS PLAGUE DETECTION KIT
FDA 510(k) clearance K131729 · decided 2013-07-31
Clearance details
- K-number
- K131729
- Device name
- JBAIDS PLAGUE DETECTION KIT
- Applicant
- Biofire Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-12
- Decision date
- 2013-07-31
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- OIH
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- 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.