SwimCount Sperm Quality Test
FDA 510(k) clearance K183602 · decided 2019-06-27
Clearance details
- K-number
- K183602
- Device name
- SwimCount Sperm Quality Test
- Applicant
- Motilitycount Aps
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-06-27
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- POV
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Valby, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.