The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Vancomycin.
| Device ID | K980348 |
| 510k Number | K980348 |
| Device Name: | ETEST VANCOMYCIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom 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 | 1998-01-28 |
| Decision Date | 1998-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378950 | K980348 | 000 |
| 03573026253295 | K980348 | 000 |
| 03573026618780 | K980348 | 000 |