The following data is part of a premarket notification filed by Liofilchem S. R. L. with the FDA for Mts Imipenem-relebactam 0.002/4-32/4 µg/ml.
| Device ID | K191809 |
| 510k Number | K191809 |
| Device Name: | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Liofilchem S. R. L. Via Scozia Zona Ind.le Roseto Degli Abruzzi, IT 64026 |
| Contact | Fabio Brocco |
| Correspondent | Anne R. Windau Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, OH 44145 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-05 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055182872466 | K191809 | 000 |