The following data is part of a premarket notification filed by Ab Biodisk North America, Inc. with the FDA for Amoxicillin/clavulanic Acid 2/1.
| Device ID | K950328 |
| 510k Number | K950328 |
| Device Name: | AMOXICILLIN/CLAVULANIC ACID 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 | 1995-01-19 |
| Decision Date | 1995-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026376581 | K950328 | 000 |
| 03573026252328 | K950328 | 000 |
| 03573026623609 | K950328 | 000 |