Clearance Summary
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC received FDA 510(k) clearance under submission number K964491, sponsored by Unipath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1997-02-07.
- Submission: K964491
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1620
- Decision date: 1997-02-07
Classification & Regulation
This clearance is catalogued under FDA product code JTN and 21 CFR 866.1620, within the Microbiology review panel as a Class II device.