Clearance Summary
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK received FDA 510(k) clearance under submission number K974027, sponsored by Alfa Biotech (Uk) , Ltd.. 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 1998-02-02.
- Submission: K974027
- Applicant / Sponsor: Alfa Biotech (Uk) , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1998-02-02
Classification & Regulation
This clearance is catalogued under FDA product code CDP and 21 CFR 862.1710, within the Clinical Chemistry review panel as a Class II device.