Cleared Traditional

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

K182886 · Beckman Coulter · Immunology
Sep 2019
Decision
326d
Days
Class 2
Risk

About This 510(k) Submission

K182886 is an FDA 510(k) clearance for the Cytomics FC 500 Series (MPL or MCL) Flow Cytometer, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on September 6, 2019, 326 days after receiving the submission on October 15, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K182886 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2018
Decision Date September 06, 2019
Days to Decision 326 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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