Cleared Traditional

RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS

K990327 · Coulter Corp. · Hematology
Apr 1999
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K990327 is an FDA 510(k) clearance for the RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on April 26, 1999, 83 days after receiving the submission on February 2, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K990327 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1999
Decision Date April 26, 1999
Days to Decision 83 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