510(k) K252114

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL by Liofilchem s.r.l. — Product Code JWY

K252114 is an FDA 510(k) premarket notification submitted by Liofilchem s.r.l. for the device "MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL". The FDA issued a decision of Substantially Equivalent on October 2, 2025. 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.