The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Submission For Azithromycin/s. Pneumoniae.
| Device ID | K970473 |
| 510k Number | K970473 |
| Device Name: | ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DAVAGEN 10 S-171 36 Solna, SE |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK DAVAGEN 10 S-171 36 Solna, SE |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-05-01 |