Clearance Summary
DE-TOX TUBES A AND DE-TOX TUBES B received FDA 510(k) clearance under submission number K904326, sponsored by Dyna-Tek Industries. 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 1991-01-17.
- Submission: K904326
- Applicant / Sponsor: Dyna-Tek Industries
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2270
- Decision date: 1991-01-17
Classification & Regulation
This clearance is catalogued under FDA product code DPA and 21 CFR 862.2270, within the Clinical Chemistry review panel as a Class I device.