510(k) K041600
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2004
- Date Received
- June 14, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Quality Control, Semen Analysis
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type
A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.