The following data is part of a premarket notification filed by Liofilchem S.r.l. with the FDA for Mts Imipenem 0.016-256 µg/ml.
| Device ID | K191908 |
| 510k Number | K191908 |
| Device Name: | MTS Imipenem 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 | 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 | 2019-07-16 |
| Decision Date | 2019-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18055182872302 | K191908 | 000 |
| 28055182872293 | K191908 | 000 |
| 08055182872282 | K191908 | 000 |