The following data is part of a premarket notification filed by Ab Biodisk with the FDA for E Test For Ofloxacin.
| Device ID | K946364 |
| 510k Number | K946364 |
| Device Name: | E TEST FOR OFLOXACIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-19 |
| Decision Date | 1995-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378394 | K946364 | 000 |
| 03573026253073 | K946364 | 000 |