Clearance Summary
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 received FDA 510(k) clearance under submission number K030849, sponsored by N-Dia, Inc.. 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 2004-02-02.
- Submission: K030849
- Applicant / Sponsor: N-Dia, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2004-02-02
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.