The following data is part of a premarket notification filed by Liofilchem S.r.l. with the FDA for Liofilchem Mic Test Strip (mts) Meropenem 0.002-32.0 Ug/ml.
| Device ID | K162854 |
| 510k Number | K162854 |
| Device Name: | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 Ug/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 1651-A Crossings Parkway 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 | 2016-10-12 |
| Decision Date | 2016-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18055182870094 | K162854 | 000 |