The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Ekf- Diagnostic Hemo_control Hemoglobin Measurement System; Ekf-diagnostic Hemoglobin Microcuvettes (modified Curvette W.
| Device ID | K110393 |
| 510k Number | K110393 |
| Device Name: | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W |
| Classification | System, Hemoglobin, Automated |
| Applicant | EKF-DIAGNOSTIC GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski EKF-DIAGNOSTIC GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-03-04 |
| Summary: | summary |