Clearance Summary
ANTIGENZ CHLAMYDIA received FDA 510(k) clearance under submission number K905402, sponsored by Northumbria Biologicals , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1991-03-11.
- Submission: K905402
- Applicant / Sponsor: Northumbria Biologicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 1991-03-11
Classification & Regulation
This clearance is catalogued under FDA product code GZB and 21 CFR 882.5880, within the Neurology review panel as a Class II device.