Clearance Summary
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK received FDA 510(k) clearance under submission number K944697, sponsored by Organon Teknika Corp.. 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 1995-02-22.
- Submission: K944697
- Applicant / Sponsor: Organon Teknika Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 1995-02-22
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.