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

34 devices

26-34 of 34

Cleared Aug 01, 2017

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

Microbiology · 36d

Cleared Jun 07, 2017

Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

Microbiology · 85d

Cleared May 25, 2017

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL

Microbiology · 59d

Cleared Mar 14, 2017

Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL

Microbiology · 89d

Cleared Feb 22, 2017

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

Microbiology · 92d

Cleared Dec 19, 2016

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml

Microbiology · 68d

Cleared Jul 12, 2016

Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL

Microbiology · 77d

Cleared Jun 22, 2016

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

Microbiology · 190d

Cleared Mar 31, 2016

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

Microbiology · 99d