The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Doripenem - Antimicrobial Susceptibility Test - Mic At 0.002-32 Ug/ml.
| Device ID | K081325 |
| 510k Number | K081325 |
| Device Name: | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anette Engelhardt |
| Correspondent | Anette Engelhardt 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 | 2008-05-12 |
| Decision Date | 2008-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026377472 | K081325 | 000 |
| 03573026257736 | K081325 | 000 |
| 03573026623715 | K081325 | 000 |