Clearance Summary
AMNIOTEST(TM) received FDA 510(k) clearance under submission number K914419, sponsored by Pro-Lab, 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 1993-09-01.
- Submission: K914419
- Applicant / Sponsor: Pro-Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1993-09-01
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.