Cleared Traditional

K910745 - HEMOGLOBIN REAGENT
(FDA 510(k) Clearance)

K910745 · Toa Medical Electronics USA, Inc. · Hematology device

Jul 1991

Decision

140d

Days

Class 2

Risk

K910745 is an FDA 510(k) clearance for the HEMOGLOBIN REAGENT. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on July 11, 1991, 140 days after receiving the submission on February 21, 1991.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number	K910745 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 21, 1991
Decision Date	July 11, 1991
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—