Cleared Traditional

K912494 - SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
(FDA 510(k) Clearance)

K912494 · Toa Medical Electronics USA, Inc. · Hematology

Sep 1991

Decision

97d

Days

Class 2

Risk

K912494 is an FDA 510(k) clearance for the SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL).

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on September 10, 1991, 97 days after receiving the submission on June 5, 1991.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number	K912494 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1991
Decision Date	September 10, 1991
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement