The following data is part of a premarket notification filed by Liofilchem S.r.l with the FDA for Liofilchem Mic Test Strip (mts)-vancomycin 0.016 -256 Ug/ml.
| Device ID | K153687 |
| 510k Number | K153687 |
| Device Name: | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 Ug/mL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Liofilchem S.r.l 64026 Roseto Degli Abruzzi, IT |
| Contact | Fabio Brocci |
| 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 | 2015-12-23 |
| Decision Date | 2016-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18055182870032 | K153687 | 000 |