Clearance Summary
NANOSEP N10 received FDA 510(k) clearance under submission number K935496, sponsored by Intersep , 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 1994-04-26.
- Submission: K935496
- Applicant / Sponsor: Intersep , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2310
- Decision date: 1994-04-26
Classification & Regulation
This clearance is catalogued under FDA product code JJH and 21 CFR 862.2310, within the Clinical Chemistry review panel as a Class I device.