510(k) K770401

LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JJI

K770401 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE". The FDA issued a decision of Substantially Equivalent on April 26, 1977. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.