Cleared Traditional

EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

K031898 · Ekf Diagnostic GmbH · Hematology
Sep 2003
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K031898 is an FDA 510(k) clearance for the EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Ekf Diagnostic GmbH (Egale, US). The FDA issued a Cleared decision on September 24, 2003, 97 days after receiving the submission on June 19, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K031898 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2003
Decision Date September 24, 2003
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620