Cleared Special

CELL-DYN Emerald 22 AL System

K190294 · Abbott Laboratories · Hematology
Mar 2019
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K190294 is an FDA 510(k) clearance for the CELL-DYN Emerald 22 AL System, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on March 15, 2019, 32 days after receiving the submission on February 11, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K190294 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2019
Decision Date March 15, 2019
Days to Decision 32 days
Submission Type Special
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