510(k) K812993

MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK by General Diagnostics — Product Code JTN

K812993 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. General Diagnostics has at least 10 other 510(k) clearances on record.