510(k) K790899

BACTEC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KLP

K790899 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC". The FDA issued a decision of Substantially Equivalent on May 23, 1979. The device falls under product code KLP (Amikacin Serum Assay), a Class II device regulated under 21 CFR 862.3035. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.