The following data is part of a premarket notification filed by Liofilchem S.r.l. with the FDA for Liofilchem Mic Test Strip (mts)- Ceftolozane/tazobactam 0.016/4 - 256/4 Mcg/ml.
| Device ID | K161175 |
| 510k Number | K161175 |
| Device Name: | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 Mcg/mL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | LIOFILCHEM S.R.L. 64026 ROSETO DEGHLI Abruzzi, IT |
| Contact | Fabio Bracco |
| 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 | 2016-04-26 |
| Decision Date | 2016-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18055182870063 | K161175 | 000 |