The following data is part of a premarket notification filed by Liofilchem S.r.l. with the FDA for Liofilchem Mic Test Strip (mts) Telavancin 0.016 - 256.0 µg/ml.
| Device ID | K163517 |
| 510k Number | K163517 |
| Device Name: | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 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 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 | 2016-12-15 |
| Decision Date | 2017-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055182870219 | K163517 | 000 |