The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Submission For Azithromycin.
| Device ID | K961519 |
| 510k Number | K961519 |
| Device Name: | ETEST SUBMISSION FOR AZITHROMYCIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK DAVAGEN 10 S-171 36 Solna, SE |
| Contact | Ann Bolmstrom |
| Correspondent | Ann 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 | 1996-04-22 |
| Decision Date | 1996-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026376741 | K961519 | 000 |
| 03573026252380 | K961519 | 000 |
| 03573026618803 | K961519 | 000 |