Cleared Special

EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

K110393 · Ekf Diagnostic GmbH · Hematology

Mar 2011

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K110393 is an FDA 510(k) clearance for the EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W, 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 March 4, 2011, 21 days after receiving the submission on February 11, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number	K110393 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2011
Decision Date	March 04, 2011
Days to Decision	21 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF