K241348

Substantially Equivalent

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

Applicant: Motilitycount Aps
Product code: MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2024-05-13
Decision date: 2025-01-31
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.