510(k) K964421

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK by Remel, L.P. — Product Code JTN

K964421 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK". The FDA issued a decision of Substantially Equivalent on December 6, 1996. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Remel, L.P. has at least 9 other 510(k) clearances on record.