ETEST CEFTRIAXONE
FDA 510(k) clearance K980345 · decided 1998-05-27
Clearance details
- K-number
- K980345
- Device name
- ETEST CEFTRIAXONE
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 1998-01-29
- Decision date
- 1998-05-27
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a recall (Z-1523-2017) | BioMerieux SA | 2017-03-21 |
| ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). recall (Z-1532-2017) | BioMerieux SA | 2017-03-21 |