510(k) K240252

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System by Beckman Coulter, Inc. — Product Code GKZ

K240252 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System". The FDA issued a decision of Substantially Equivalent on July 5, 2024. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.