The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Linezolid.
| Device ID | K002139 |
| 510k Number | K002139 |
| Device Name: | ETEST LINEZOLID |
| Classification | Discs, Elution |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolmstorm |
| Correspondent | Anne Bolmstorm AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Product Code | LTX |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378097 | K002139 | 000 |
| 03573026253677 | K002139 | 000 |
| 03573026619671 | K002139 | 000 |