The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest/ceftriaxone/haemophilus/pneumococcus.
| Device ID | K945433 |
| 510k Number | K945433 |
| Device Name: | ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-03-17 |