SwimCount Sperm Quality Test— 510(k) K183602

Substantially Equivalent

Motilitycount Aps

FDA 510(k) clearance K183602 for SwimCount Sperm Quality Test, Substantially Equivalent on 2019-06-27. Applicant: Motilitycount Aps.

Clearance details

Applicant: Motilitycount Aps
Product code: Code POV
Advisory panel: Hematology
Date received: 2018-12-26
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valby, DK

Download summary PDF View on FDA.gov ↗

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