Clearance Summary
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) received FDA 510(k) clearance under submission number K896031, sponsored by Concord/Portex. 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 1990-01-12.
- Submission: K896031
- Applicant / Sponsor: Concord/Portex
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1990-01-12
Classification & Regulation
This clearance is catalogued under FDA product code HIO and 21 CFR 884.1550, within the Obstetrics/Gynecology review panel as a Class I device.