Medical Device Manufacturer · IT , Abruzzi

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

35 submissions · 35 cleared · Since 2016

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

FDA 510(k) Regulatory Record - Liofilchem S. R. L. Microbiology ✕

35 devices
1-12 of 35
Cleared Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · JWY
Microbiology · 45d
Cleared Oct 02, 2025
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · JWY
Microbiology · 87d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Microbiology · 89d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Microbiology · 121d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · JWY
Microbiology · 85d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · JWY
Microbiology · 141d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY
Microbiology · 56d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Microbiology · 63d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · JWY
Microbiology · 50d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · JWY
Microbiology · 49d
Cleared May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · JWY
Microbiology · 51d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · JWY
Microbiology · 43d
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