510(k) K953994

SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM by Becton Dickinson Vacutainer Systems — Product Code JKA

K953994 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.