The following data is part of a premarket notification filed by Ab Biodisk North America, Inc. with the FDA for System U3 For Gentamicin.
| Device ID | K983252 |
| 510k Number | K983252 |
| Device Name: | SYSTEM U3 FOR GENTAMICIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK NORTH AMERICA, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK NORTH AMERICA, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-11-20 |