Clearance Summary
IRISPEC,CA/CB/CC received FDA 510(k) clearance under submission number K072640, sponsored by Iris Diagnostics. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2007-12-21.
- Submission: K072640
- Applicant / Sponsor: Iris Diagnostics
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2007-12-21
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.