510(k) K865021

BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTA

K865021 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.