Medical Device Manufacturer · IT , Abruzzi

Liofilchem S. R. L. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 2016

34

Total

34

Cleared

0

Denied

FDA 510(k) cleared devices by Liofilchem S. R. L. Microbiology ✕

34 devices

1-12 of 34

Cleared Oct 02, 2025

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Microbiology · 87d

Cleared Aug 20, 2025

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

Microbiology · 89d

Cleared Jan 30, 2025

MTS Ceftobiprole 0.002-32 µg/mL

Microbiology · 121d

Cleared May 18, 2023

ComASP Cefiderocol 0.008-128

Microbiology · 85d

Cleared Oct 20, 2021

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

Microbiology · 141d

Cleared Mar 20, 2020

MTS Omadacycline 0.002 - 32 ug/mL

Microbiology · 56d

Cleared Oct 31, 2019

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

Microbiology · 63d

Cleared Sep 04, 2019

MTS Imipenem 0.016-256 µg/mL

Microbiology · 50d

Cleared Aug 23, 2019

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

Microbiology · 49d

Cleared May 29, 2019

MTS Doxycycline 0.016 - 256 µg/mL

Microbiology · 51d

Cleared Mar 22, 2019

MTS Gentamicin 0.016 - 256 µg/mL

Microbiology · 43d

Cleared Mar 19, 2019

MTS Ciprofloxacin 0.002 - 32 µg/mL

Microbiology · 90d