The following data is part of a premarket notification filed by Liofilchem S.r.l with the FDA for Liofilchem Mic Test Strip (mts) -dalbavancin At 0.002 - 32 Ug/ml.
| Device ID | K153569 |
| 510k Number | K153569 |
| Device Name: | Liofilchem MIC Test Strip (MTS) -Dalbavancin At 0.002 - 32 Ug/ml |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | LIOFILCHEM S.R.L 64026 ROSETO DEGLI Abruzzi, IT |
| 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 | 2015-12-15 |
| Decision Date | 2016-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18055182870001 | K153569 | 000 |