Cleared Traditional

COULTER 5P CONTROL

K885028 · Coulter Electronics, Inc. · Hematology
Feb 1989
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K885028 is an FDA 510(k) clearance for the COULTER 5P CONTROL, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 16, 1989, 73 days after receiving the submission on December 5, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K885028 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1988
Decision Date February 16, 1989
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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