510(k) K041600
K041600 is an FDA 510(k) premarket notification submitted by Medical Electronics Systems , Ltd. for the device "QWIKCHECK-BEADS". The FDA issued a decision of Substantially Equivalent on July 27, 2004. The device falls under product code NRF (Material, Quality Control, Semen Analysis), a Class II device regulated under 21 CFR 864.8625.
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.