Clearance Summary
FETAL BLOOD SAMPLING KIT #1560 received FDA 510(k) clearance under submission number K831459, sponsored by Transidyne General Corp.. 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 1983-06-30.
- Submission: K831459
- Applicant / Sponsor: Transidyne General Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1560
- Decision date: 1983-06-30
Classification & Regulation
This clearance is catalogued under FDA product code HGW and 21 CFR 884.1560, within the Obstetrics/Gynecology review panel as a Class II device.