Clearance Summary
QUICKVUE ADVANCE PH AND AMINES GLL TEST received FDA 510(k) clearance under submission number K040008, sponsored by Quidel 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 2004-04-29.
- Submission: K040008
- Applicant / Sponsor: Quidel Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1550
- Decision date: 2004-04-29
Classification & Regulation
This clearance is catalogued under FDA product code CEN and 21 CFR 862.1550, within the Clinical Chemistry review panel as a Class I device.