Cleared Traditional

K914744 - SYSMEX NE-1500, MODIFICATION
(FDA 510(k) Clearance)

K914744 · Toa Medical Electronics USA, Inc. · Hematology
Dec 1991
Decision
69d
Days
Class 2
Risk

K914744 is an FDA 510(k) clearance for the SYSMEX NE-1500, MODIFICATION, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on December 30, 1991, 69 days after receiving the submission on October 22, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K914744 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1991
Decision Date December 30, 1991
Days to Decision 69 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