510(k) K180330

Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL by Liofilchem S.R.L. — Product Code JWY

K180330 is an FDA 510(k) premarket notification submitted by Liofilchem S.R.L. for the device "Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL". The FDA issued a decision of Substantially Equivalent on Mar 15, 2018. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Liofilchem S.R.L. has 37 other 510(k) clearances on record.