The following data is part of a premarket notification filed by Ab Biomerieux with the FDA for Etest Voriconazole 0.002-32 Ug/ml.
| Device ID | K082534 |
| 510k Number | K082534 |
| Device Name: | ETEST VORICONAZOLE 0.002-32 UG/ML |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | AB BIOMERIEUX DALVAGEN 10 Solna, SE 16956 |
| Contact | Anette Engelhardt |
| Correspondent | Anette Engelhardt AB BIOMERIEUX 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 | 2008-09-02 |
| Decision Date | 2009-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378974 | K082534 | 000 |