Cleared Traditional

COULTER FLOW RETICULOCYTE REAGENT

K885332 · Coulter Electronics, Inc. · Hematology
Feb 1989
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K885332 is an FDA 510(k) clearance for the COULTER FLOW RETICULOCYTE REAGENT, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 22, 1989, 56 days after receiving the submission on December 28, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K885332 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1988
Decision Date February 22, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

Similar Devices — GKL Counter, Cell, Automated (particle Counter)

All 129
Glocyte Automated Cell Counter System
K152776 · Advanced Instruments, Inc. · May 2016
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
K091539 · Iris Diagnostics · Aug 2010
HEMOCUE WBC SYSTEM
K071652 · Hemocue AB · Oct 2007
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · Bayer Healthcare, LLC · Dec 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235 · Iris International, Inc. · Mar 2005
SYSMEX POCH-100I
K032677 · Sysmex America, Inc. · Feb 2004