Medical Device Manufacturer · IT , Abruzzi

Liofilchem S. R. L.

34 submissions · 34 cleared · Since 2016
34
Total
34
Cleared
0
Denied

Liofilchem S. R. L. — FDA 510(k) Submissions

Liofilchem S. R. L. has submitted 34 FDA 510(k) premarket notifications since 2016, of which 34 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems . Use the specialty filter in the sidebar to narrow results.

34 devices
1–25 of 34
MTS Aztreonam-Avibactam 0.016/4 - 256/4 ?g/mL
K252114 · JWY Manual Antimicrobial... · Microbiology
Oct 2025 87d
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 ?g/mL (SUD)
K251580 · JWY Manual Antimicrobial... · Microbiology
Aug 2025 89d
MTS Ceftobiprole 0.002-32 ?g/mL
K243202 · JWY Manual Antimicrobial... · Microbiology
Jan 2025 121d
ComASP Cefiderocol 0.008-128
K230479 · JWY Manual Antimicrobial... · Microbiology
May 2023 85d
MTS Piperacillin-tazobactam 0.016/4 - 256/4?g/mL
K211672 · JWY Manual Antimicrobial... · Microbiology
Oct 2021 141d
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY Manual Antimicrobial... · Microbiology
Mar 2020 56d
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ?g/mL
K192345 · JWY Manual Antimicrobial... · Microbiology
Oct 2019 63d
MTS Imipenem 0.016-256 ?g/mL
K191908 · JWY Manual Antimicrobial... · Microbiology
Sep 2019 50d
MTS Imipenem-relebactam 0.002/4-32/4 ?g/mL
K191809 · JWY Manual Antimicrobial... · Microbiology
Aug 2019 49d
MTS Doxycycline 0.016 - 256 ?g/mL
K190914 · JWY Manual Antimicrobial... · Microbiology
May 2019 51d
MTS Gentamicin 0.016 - 256 ?g/mL
K190252 · JWY Manual Antimicrobial... · Microbiology
Mar 2019 43d
MTS Ciprofloxacin 0.002 - 32 ?g/mL
K183527 · JWY Manual Antimicrobial... · Microbiology
Mar 2019 90d
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · JWY Manual Antimicrobial... · Microbiology
Jan 2019 59d
MTS Levofloxacin 0.002 - 32 ?g/mL
K183115 · JWY Manual Antimicrobial... · Microbiology
Dec 2018 41d
MTS Omadacycline 0.002-32 ?g/mL
K182922 · JWY Manual Antimicrobial... · Microbiology
Dec 2018 56d
MTS Eravacycline 0.002 - 32 ?g/mL
K182557 · JWY Manual Antimicrobial... · Microbiology
Nov 2018 46d
MTS Penicillin 0.002- 32 ?g/mL
K181889 · JWY Manual Antimicrobial... · Microbiology
Sep 2018 62d
MTS Plazomicin 0.016-256 ?g/mL
K181708 · JWY Manual Antimicrobial... · Microbiology
Jul 2018 33d
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886 · JWY Manual Antimicrobial... · Microbiology
May 2018 44d
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL
K180339 · JWY Manual Antimicrobial... · Microbiology
Apr 2018 56d
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330 · JWY Manual Antimicrobial... · Microbiology
Mar 2018 37d
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL
K173817 · JWY Manual Antimicrobial... · Microbiology
Feb 2018 75d
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ?g/mL
K173307 · JWY Manual Antimicrobial... · Microbiology
Dec 2017 62d
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
K172542 · JWY Manual Antimicrobial... · Microbiology
Oct 2017 61d
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ?g/mL
K172109 · JWY Manual Antimicrobial... · Microbiology
Sep 2017 76d
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