The following data is part of a premarket notification filed by Ab Biomerieux with the FDA for Etest Moxifloxacin 0.002-32 Ug/ml.
| Device ID | K093604 |
| 510k Number | K093604 |
| Device Name: | ETEST MOXIFLOXACIN 0.002-32 UG/ML |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIOMERIEUX DALVAGEN 10 Solna, SE 16956 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson AB BIOMERIEUX 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 | 2009-11-20 |
| Decision Date | 2010-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378240 | K093604 | 000 |
| 03573026253509 | K093604 | 000 |
| 03573026623708 | K093604 | 000 |