Cleared Traditional

COULTER MAXM W/ AUTOLOADER

K922704 · Coulter Electronics, Inc. · Hematology
Jul 1992
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K922704 is an FDA 510(k) clearance for the COULTER MAXM W/ AUTOLOADER, 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 July 27, 1992, 52 days after receiving the submission on June 5, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K922704 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1992
Decision Date July 27, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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