510(k) K904795

FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GKH

K904795 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 31, 1990. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.