Company · IT
Liofilchem s.r.l.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 35 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2026 | K260696 | MTS Gepotidacin 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| Oct 2, 2025 | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 20, 2025 | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) Liofilchem s.r.l., IT | JWY |
| Jan 30, 2025 | K243202 | MTS Ceftobiprole 0.002-32 µg/mL Liofilchem s.r.l., IT | JWY |
| May 18, 2023 | K230479 | ComASP Cefiderocol 0.008-128 Liofilchem s.r.l., IT | JWY |
| Oct 20, 2021 | K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 20, 2020 | K200180 | MTS Omadacycline 0.002 - 32 ug/mL Liofilchem s.r.l., IT | JWY |
| Oct 31, 2019 | K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL Liofilchem s.r.l., IT | JWY |
| Sep 4, 2019 | K191908 | MTS Imipenem 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 23, 2019 | K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL Liofilchem s.r.l., IT | JWY |
| May 29, 2019 | K190914 | MTS Doxycycline 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 22, 2019 | K190252 | MTS Gentamicin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 19, 2019 | K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Jan 11, 2019 | K183140 | MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l., IT | JWY |
| Dec 20, 2018 | K183115 | MTS Levofloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 14, 2018 | K182922 | MTS Omadacycline 0.002-32 µg/mL Liofilchem s.r.l., IT | JWY |
| Nov 2, 2018 | K182557 | MTS Eravacycline 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Sep 13, 2018 | K181889 | MTS Penicillin 0.002- 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Jul 31, 2018 | K181708 | MTS Plazomicin 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| May 18, 2018 | K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL Liofilchem s.r.l., IT | JWY |
| Apr 4, 2018 | K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 15, 2018 | K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s.r.l., IT | JWY |
| Feb 28, 2018 | K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 19, 2017 | K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL Liofilchem s.r.l., IT | JWY |
| Oct 23, 2017 | K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. Liofilchem s.r.l., IT | JWY |
| Sep 27, 2017 | K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 1, 2017 | K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Jun 7, 2017 | K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| May 25, 2017 | K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 14, 2017 | K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL Liofilchem s.r.l., IT | JWY |
| Feb 22, 2017 | K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 19, 2016 | K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml Liofilchem s.r.l., IT | JWY |
| Jul 12, 2016 | K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL Liofilchem s.r.l., IT | JWY |
| Jun 22, 2016 | K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml Liofilchem s.r.l., IT | JWY |
| Mar 31, 2016 | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL Liofilchem s.r.l., IT | JWY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||