Cleared Traditional

COULTER MH009

K922181 · Coulter Electronics, Inc. · Hematology
Aug 1992
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K922181 is an FDA 510(k) clearance for the COULTER MH009, 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 August 17, 1992, 101 days after receiving the submission on May 8, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K922181 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1992
Decision Date August 17, 1992
Days to Decision 101 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