510(k) K182922

MTS Omadacycline 0.002-32 µg/mL by Liofilchem s.r.l. — Product Code JWY

K182922 is an FDA 510(k) premarket notification submitted by Liofilchem s.r.l. for the device "MTS Omadacycline 0.002-32 µg/mL". The FDA issued a decision of Substantially Equivalent on December 14, 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 at least 10 other 510(k) clearances on record.