Liofilchem S. R. L. is one of 126 FDA 510(k) medical device manufacturers from Italy in the dataset, ranked by real submission volume.
Liofilchem S. R. L. - FDA 510(k) Cleared Devices
Recent clearances: MTS Gepotidacin 0.016-256 µg/mL, MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL, MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
35
Total
35
Cleared
0
Denied
Liofilchem S. R. L. has 35 FDA 510(k) cleared microbiology devices. Based in Abruzzi, IT.
Latest FDA clearance: Apr 2026. Active since 2016.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Laboratory Specialists, Inc. as regulatory consultant. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Liofilchem S. R. L.
35 devices
Cleared
Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
Microbiology
45d
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