Cleared Traditional

COULTER MH017

K921567 · Coulter Electronics, Inc. · Hematology
Jul 1992
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K921567 is an FDA 510(k) clearance for the COULTER MH017, 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 6, 1992, 95 days after receiving the submission on April 2, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K921567 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1992
Decision Date July 06, 1992
Days to Decision 95 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