Clearance Summary
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG received FDA 510(k) clearance under submission number K093383, sponsored by bioMerieux, 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 2010-07-06.
- Submission: K093383
- Applicant / Sponsor: bioMerieux, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.2570
- Decision date: 2010-07-06
Classification & Regulation
This clearance is catalogued under FDA product code OOI and 21 CFR 862.2570, within the Clinical Chemistry review panel as a Class II device.