Clearance Summary
DiaSpect Tm, DiaSpect Tm Cuvettes received FDA 510(k) clearance under submission number K172173, sponsored by Ekf-Diagnostic GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2018-04-06.
- Submission: K172173
- Applicant / Sponsor: Ekf-Diagnostic GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5620
- Decision date: 2018-04-06
Classification & Regulation
This clearance is catalogued under FDA product code GKR and 21 CFR 864.5620, within the Hematology review panel as a Class II device.