MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992

About This 510(k) Submission

K002456 is an FDA 510(k) clearance for the MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton Dickinson Vacutainer Systems (Franklin Lakes, US). The FDA issued a Cleared decision on November 2, 2000, 84 days after receiving the submission on August 10, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.