510(k) K974678

B-D AUTO-INJECTOR by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KZH

K974678 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "B-D AUTO-INJECTOR". The FDA issued a decision of Substantially Equivalent on May 29, 1998. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.