Cleared Special

Hemo Control (optional Add Pack Hemo Control DM)

K200909 · Ekf Diagnostic GmbH · Hematology
Jun 2020
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K200909 is an FDA 510(k) clearance for the Hemo Control (optional Add Pack Hemo Control DM), a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on June 12, 2020, 67 days after receiving the submission on April 6, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K200909 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2020
Decision Date June 12, 2020
Days to Decision 67 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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