The following data is part of a premarket notification filed by Ab Biodisk North America, Inc. with the FDA for Etest For Ampicillin/sulbactam 2/1.
| Device ID | K935519 |
| 510k Number | K935519 |
| Device Name: | ETEST FOR AMPICILLIN/SULBACTAM 2/1 |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK NORTH AMERICA, INC. PYRAMIDVAGEN, 7 S-17136 Solna, Sweden, SE |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK NORTH AMERICA, INC. PYRAMIDVAGEN, 7 S-17136 Solna, Sweden, SE |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026376680 | K935519 | 000 |
| 03573026252427 | K935519 | 000 |
| 03573026619817 | K935519 | 000 |