FDA 510(k) Applications Submitted by Fabio Brocco

FDA 510(k) Number Submission Date Device Name Applicant
K180330 02/06/2018 Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s. r. l.
K180339 02/07/2018 Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL Liofilchem s. r. l.
K170772 03/14/2017 Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 ?g/mL Liofilchem s.r.l.
K170892 03/27/2017 Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 ?g/mL Liofilchem s. r. l.
K180886 04/04/2018 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL Liofilchem s. r. l.
K171906 06/26/2017 Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l.
K181708 06/28/2018 MTS Plazomicin 0.016-256 ?g/mL Liofilchem s. r. l.
K172109 07/13/2017 Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ?g/mL Liofilchem s. r. l.
K181889 07/13/2018 MTS Penicillin 0.002- 32 ?g/mL Liofilchem s. r. l.
K172542 08/23/2017 Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. Liofilchem s. r. l.
K182557 09/17/2018 MTS Eravacycline 0.002 - 32 ?g/mL Liofilchem s. r. l.
K162854 10/12/2016 Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml Liofilchem s.r.l.
K173307 10/18/2017 Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ?g/mL Liofilchem s. r. l.
K182922 10/19/2018 MTS Omadacycline 0.002-32 ?g/mL Liofilchem s. r. l.
K183115 11/09/2018 MTS Levofloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l.
K183140 11/13/2018 MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l.
K163298 11/22/2016 Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ?g/mL Liofilchem s. r. l.
K153569 12/15/2015 Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml LIOFILCHEM S.R.L
K163517 12/15/2016 Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ?g/mL LIOFILCHEM S.R.L.
K173817 12/15/2017 Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL Liofilchem s. r. l.


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