Clearance Summary
AMNISCREEN HOME DETECTION LINER KIT received FDA 510(k) clearance under submission number K071100, sponsored by Common Sense , Ltd.. 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 2007-10-15.
- Submission: K071100
- Applicant / Sponsor: Common Sense , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1550
- Decision date: 2007-10-15
Classification & Regulation
This clearance is catalogued under FDA product code CEN and 21 CFR 862.1550, within the Clinical Chemistry review panel as a Class I device.