ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
FDA 510(k) clearance K192050 · decided 2019-09-27
Clearance details
- K-number
- K192050
- Device name
- ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
- Applicant
- Biomerieux S.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-31
- Decision date
- 2019-09-27
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Marcy L'Etoile, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 recall (Z-0851-2023) | Biomerieux Inc | 2023-01-04 |