ETEST FOR QUINUPRISTIN/DALFOPRISTIN
FDA 510(k) clearance K992993 · decided 1999-11-16
Clearance details
- K-number
- K992993
- Device name
- ETEST FOR QUINUPRISTIN/DALFOPRISTIN
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 1999-09-07
- Decision date
- 1999-11-16
- Days to decision
- 70 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 LINEZOLID (K002139) | Ab Biodisk | 2000-11-08 |
Recalls involving this device
No recalls on record reference this clearance.