The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest For Antifungal Suscepttibility Testing.
| Device ID | K040560 |
| 510k Number | K040560 |
| Device Name: | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-03 |
| Decision Date | 2004-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026616014 | K040560 | 000 |
| 03573026377717 | K040560 | 000 |
| 03573026252885 | K040560 | 000 |
| 03573026253318 | K040560 | 000 |
| 03573026623562 | K040560 | 000 |
| 03573026377731 | K040560 | 000 |