DiaSpect Tm, DiaSpect Tm Cuvettes— 510(k) K172173
Substantially EquivalentEkf-Diagnostic GmbH
FDA 510(k) clearance K172173 for DiaSpect Tm, DiaSpect Tm Cuvettes, Substantially Equivalent on 2018-04-06. Applicant: Ekf-Diagnostic GmbH.
Clearance details
- Applicant
- Ekf-Diagnostic GmbH
- Product code
- Code GKR
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barleben, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.