Cleared Traditional

DxH 520 Hematology Instrument

K181475 · Beckman Coulter · Hematology
Mar 2019
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K181475 is an FDA 510(k) clearance for the DxH 520 Hematology Instrument, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on March 1, 2019, 270 days after receiving the submission on June 4, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K181475 FDA.gov
FDA Decision Cleared SESU
Date Received June 04, 2018
Decision Date March 01, 2019
Days to Decision 270 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