K172173

Substantially Equivalent

DiaSpect Tm, DiaSpect Tm Cuvettes

Applicant: Ekf-Diagnostic GmbH
Product code: GKR
Advisory panel: Hematology
Date received: 2017-07-19
Decision date: 2018-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barleben, DE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.