Clearance Summary
FIAX 420 DILUTOR received FDA 510(k) clearance under submission number K843621, sponsored by Intl. Diagnostic Technology. 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 1984-09-28.
- Submission: K843621
- Applicant / Sponsor: Intl. Diagnostic Technology
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1984-09-28
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.