Clearance Summary
AMNIO CENTESES KIT W/NEEDLE received FDA 510(k) clearance under submission number K830019, sponsored by Universal Medical Instrument 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 1983-01-18.
- Submission: K830019
- Applicant / Sponsor: Universal Medical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1983-01-18
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.