Clearance Summary
FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) received FDA 510(k) clearance under submission number K872088, 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 1987-08-14.
- Submission: K872088
- Applicant / Sponsor: Irvine Scientific
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1987-08-14
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.