510(k) K172542

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. by Liofilchem S.R.L. — Product Code JWY

K172542 is an FDA 510(k) premarket notification submitted by Liofilchem S.R.L. for the device "Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.". The FDA issued a decision of Substantially Equivalent on Oct 23, 2017. 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.