510(k) K882767

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM by Toa Medical Electronics USA, Inc. — Product Code GKH

K882767 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.