510(k) K181708

MTS Plazomicin 0.016-256 µg/mL by Liofilchem S.R.L. — Product Code JWY

K181708 is an FDA 510(k) premarket notification submitted by Liofilchem S.R.L. for the device "MTS Plazomicin 0.016-256 µg/mL". The FDA issued a decision of Substantially Equivalent on Jul 31, 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.