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510(k) K241348

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) by Motilitycount Aps — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2025
Date Received
May 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Motilitycount Aps

  • K183602 — SwimCount Sperm Quality Test (June 27, 2019)

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