SYSTEM U3
Manual Antimicrobial Susceptibility Test Systems
AB BIODISK
The following data is part of a premarket notification filed by Ab Biodisk with the FDA for System U3.
Pre-market Notification Details
| Device ID | K983890 |
| 510k Number | K983890 |
| Device Name: | SYSTEM U3 |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolstrom |
| Correspondent | Anne Bolstrom 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 | 1998-11-02 |
| Decision Date | 1999-02-18 |
Trademark Results [SYSTEM U3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYSTEM U3 75575444 not registered Dead/Abandoned |
AB Biodisk 1999-08-02 |
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