Liofilchem s.r.l.
FDA 510(k) & PMA Approved Devices — 35 products
Total Devices35
Categories1
Latest FDA decision2026-04-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260696 | MTS Gepotidacin 0.016-256 µg/mL | JWY | 2026-04-17 | View |
| 510(k) | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | JWY | 2025-10-02 | View |
| 510(k) | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | JWY | 2025-08-20 | View |
| 510(k) | K243202 | MTS Ceftobiprole 0.002-32 µg/mL | JWY | 2025-01-30 | View |
| 510(k) | K230479 | ComASP Cefiderocol 0.008-128 | JWY | 2023-05-18 | View |
| 510(k) | K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | JWY | 2021-10-20 | View |
| 510(k) | K200180 | MTS Omadacycline 0.002 - 32 ug/mL | JWY | 2020-03-20 | View |
| 510(k) | K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | JWY | 2019-10-31 | View |
| 510(k) | K191908 | MTS Imipenem 0.016-256 µg/mL | JWY | 2019-09-04 | View |
| 510(k) | K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | JWY | 2019-08-23 | View |
| 510(k) | K190914 | MTS Doxycycline 0.016 - 256 µg/mL | JWY | 2019-05-29 | View |
| 510(k) | K190252 | MTS Gentamicin 0.016 - 256 µg/mL | JWY | 2019-03-22 | View |
| 510(k) | K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | JWY | 2019-03-19 | View |
| 510(k) | K183140 | MTS Tetracycline 0.016 - 256 ug/mL | JWY | 2019-01-11 | View |
| 510(k) | K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | JWY | 2018-12-20 | View |
| 510(k) | K182922 | MTS Omadacycline 0.002-32 µg/mL | JWY | 2018-12-14 | View |
| 510(k) | K182557 | MTS Eravacycline 0.002 - 32 µg/mL | JWY | 2018-11-02 | View |
| 510(k) | K181889 | MTS Penicillin 0.002- 32 µg/mL | JWY | 2018-09-13 | View |
| 510(k) | K181708 | MTS Plazomicin 0.016-256 µg/mL | JWY | 2018-07-31 | View |
| 510(k) | K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | JWY | 2018-05-18 | View |
No matching devices.
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