Clearance Summary
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 received FDA 510(k) clearance under submission number K081767, sponsored by Amnisure International, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-01-09.
- Submission: K081767
- Applicant / Sponsor: Amnisure International, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1550
- Decision date: 2009-01-09
Classification & Regulation
This clearance is catalogued under FDA product code NQM and 21 CFR 862.1550, within the Clinical Chemistry review panel as a Class I device.