The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest For Gemifloxacin.
| Device ID | K042390 |
| 510k Number | K042390 |
| Device Name: | ETEST FOR GEMIFLOXACIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2004-11-19 |