Clearance Summary
SPERM WASHING MEDIUM #9983 & MODIFIED #9984 received FDA 510(k) clearance under submission number K874668, sponsored by Irvine Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-03-31.
- Submission: K874668
- Applicant / Sponsor: Irvine Scientific
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1988-03-31
Classification & Regulation
This clearance is catalogued under FDA product code HDR and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.