Cleared Traditional

Unicel DxH 800 Coulter Cellular Analysis System

K193124 · Beckman Coulter · Hematology
Apr 2020
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K193124 is an FDA 510(k) clearance for the Unicel DxH 800 Coulter Cellular Analysis System, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on April 16, 2020, 156 days after receiving the submission on November 12, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K193124 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2019
Decision Date April 16, 2020
Days to Decision 156 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