K110393 is an FDA 510(k) clearance for the EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K110393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | GKR - System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |