TRU FLU
FDA 510(k) clearance K133714 · decided 2014-01-03
Clearance details
- K-number
- K133714
- Device name
- TRU FLU
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-05
- Decision date
- 2014-01-03
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- PSZ
- Device class
- 2
- Regulation number
- 866.3328
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.