Cleared Traditional

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

K240252 · Beckman Coulter, Inc. · Hematology
Jul 2024
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K240252 is an FDA 510(k) clearance for the UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 5, 2024, 157 days after receiving the submission on January 30, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K240252 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2024
Decision Date July 05, 2024
Days to Decision 157 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220