The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Diaspect Tm, Diaspect Tm Cuvettes.
| Device ID | K172173 |
| 510k Number | K172173 |
| Device Name: | DiaSpect Tm, DiaSpect Tm Cuvettes |
| Classification | System, Hemoglobin, Automated |
| Applicant | EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, DE 39179 |
| Contact | Mick Fenton |
| Correspondent | Mick Fenton EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, DE 39179 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2018-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20612479234110 | K172173 | 000 |
| 20612479234103 | K172173 | 000 |
| 20612479234080 | K172173 | 000 |