K153569 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Liofilchem S. R. L. (Abruzzi, IT). The FDA issued a Cleared decision on June 22, 2016, 190 days after receiving the submission on December 15, 2015.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K153569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2015 |
| Decision Date | June 22, 2016 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |