Clearance Summary
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES received FDA 510(k) clearance under submission number K013451, sponsored by Phoenix Diagnostics, 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 2001-12-18.
- Submission: K013451
- Applicant / Sponsor: Phoenix Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 2001-12-18
Classification & Regulation
This clearance is catalogued under FDA product code CGZ and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.