Cleared Traditional

COULTER(R) MH010

K911385 · Coulter Electronics, Inc. · Hematology
Jun 1991
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K911385 is an FDA 510(k) clearance for the COULTER(R) MH010, 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 June 17, 1991, 81 days after receiving the submission on March 28, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K911385 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1991
Decision Date June 17, 1991
Days to Decision 81 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