Clearance Summary
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT received FDA 510(k) clearance under submission number K954562, sponsored by Gynetech, Inc.. 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 1995-12-22.
- Submission: K954562
- Applicant / Sponsor: Gynetech, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1995-12-22
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.