The following data is part of a premarket notification filed by Liofilchem S. R. L. with the FDA for Mts Plazomicin 0.016-256 µg/ml.
| Device ID | K181708 |
| 510k Number | K181708 |
| Device Name: | MTS Plazomicin 0.016-256 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 | Laura M. Koeth 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 | 2018-06-28 |
| Decision Date | 2018-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055182872343 | K181708 | 000 |