The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest For Quinupristin/dalfopristin.
| Device ID | K992993 |
| 510k Number | K992993 |
| Device Name: | ETEST FOR QUINUPRISTIN/DALFOPRISTIN |
| Classification | Discs, Elution |
| Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK DALVAGEN 10 Solna, SE 16956 |
| Product Code | LTX |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026253479 | K992993 | 000 |
| 03573026378530 | K992993 | 000 |