Clearance Summary
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS received FDA 510(k) clearance under submission number K823352, sponsored by American Dade. 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 1983-02-07.
- Submission: K823352
- Applicant / Sponsor: American Dade
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1983-02-07
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.