ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
FDA 510(k) clearance K102668 · decided 2010-11-17
Clearance details
- K-number
- K102668
- Device name
- ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
- Applicant
- BIOMERIEUX
- Decision
- Substantially Equivalent
- Date received
- 2010-09-16
- Decision date
- 2010-11-17
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Craponne, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 recall (Z-0830-2023) | Biomerieux Inc | 2023-01-04 |
| ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). E recall (Z-1531-2017) | BioMerieux SA | 2017-03-21 |