Clearance Summary
IRMA TRUPOINT CREATININE CONTROL KIT received FDA 510(k) clearance under submission number K050983, sponsored by International Technidyne Corporation. 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 2005-05-16.
- Submission: K050983
- Applicant / Sponsor: International Technidyne Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2005-05-16
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.