Clearance Summary
AMNIOSTAT-FLM-PG received FDA 510(k) clearance under submission number K061549, sponsored by Irvine Scientific Sales Co., 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 2006-10-18.
- Submission: K061549
- Applicant / Sponsor: Irvine Scientific Sales Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1455
- Decision date: 2006-10-18
Classification & Regulation
This clearance is catalogued under FDA product code JHG and 21 CFR 862.1455, within the Clinical Chemistry review panel as a Class II device.