510(k) K855106

IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTT

K855106 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.