Curetis Unyvero LRT Application
FDA 510(k) clearance DEN170047 · decided 2018-04-03
Clearance details
- K-number
- DEN170047
- Device name
- Curetis Unyvero LRT Application
- Applicant
- Curetis GmbH
- Decision
- Unknown
- Date received
- 2017-09-11
- Decision date
- 2018-04-03
- Days to decision
- 204 days
- Clearance type
- Direct
- 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 |
|---|---|---|
| Unyvero LRT BAL Application (K191967) | Curetis GmbH | 2019-12-20 |
Recalls involving this device
No recalls on record reference this clearance.