K172173 is an FDA 510(k) clearance for the DiaSpect Tm, DiaSpect Tm Cuvettes. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on April 6, 2018, 261 days after receiving the submission on July 19, 2017.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K172173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2017 |
| Decision Date | April 06, 2018 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| 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 |