Clearance Summary
1570 - FETAL BLOOD SAMPLING KIT received FDA 510(k) clearance under submission number K891388, 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 1989-03-28.
- Submission: K891388
- Applicant / Sponsor: Transidyne General Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1560
- Decision date: 1989-03-28
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.