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.
| Device ID | K031898 |
| 510k Number | K031898 |
| Device Name: | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-19 |
| Decision Date | 2003-09-24 |