Unyvero LRT BAL Application
FDA 510(k) clearance K191967 · decided 2019-12-20
Clearance details
- K-number
- K191967
- Device name
- Unyvero LRT BAL Application
- Applicant
- Curetis GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-07-23
- Decision date
- 2019-12-20
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- QBH
- Device class
- 2
- Regulation number
- 866.3985
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Holzgerlingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Curetis Unyvero LRT Application (DEN170047) | Curetis GmbH | 2018-04-03 |
Recalls involving this device
No recalls on record reference this clearance.