The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Quo-test A1c System.
| Device ID | K180509 |
| 510k Number | K180509 |
| Device Name: | Quo-Test A1c System |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, DE 30179 |
| Contact | Mick Fenton |
| Correspondent | Karen Golomb EKF-diagnostic GmbH Ebendorfer Chaussee 3 39179 Barleben, DE |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2019-02-16 |
| Summary: | summary |