Clearance Summary
FIAX 100 FLUOROMETER received FDA 510(k) clearance under submission number K843356, sponsored by Intl. Diagnostic Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1984-09-17.
- Submission: K843356
- Applicant / Sponsor: Intl. Diagnostic Technology
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4520
- Decision date: 1984-09-17
Classification & Regulation
This clearance is catalogued under FDA product code JZT and 21 CFR 866.4520, within the Immunology review panel as a Class I device.