Clearance Summary
IDS-ISYS IFG-I CONTROL SET received FDA 510(k) clearance under submission number K110412, sponsored by Immunodiagnostic Systems , Ltd.. 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 2011-03-16.
- Submission: K110412
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2011-03-16
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.