ETEST LINEZOLID
FDA 510(k) clearance K002139 · decided 2000-11-08
Clearance details
- K-number
- K002139
- Device name
- ETEST LINEZOLID
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 2000-07-17
- Decision date
- 2000-11-08
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- LTX
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Solna, SE
- 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 |
|---|---|---|
| ETEST FOR QUINUPRISTIN/DALFOPRISTIN (K992993) | Ab Biodisk | 1999-11-16 |
Recalls involving this device
No recalls on record reference this clearance.