Clearance Summary
QUANTASE PHE/GAL SCREENING ASSAY received FDA 510(k) clearance under submission number K984463, sponsored by Quantase , 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 1999-02-16.
- Submission: K984463
- Applicant / Sponsor: Quantase , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1555
- Decision date: 1999-02-16
Classification & Regulation
This clearance is catalogued under FDA product code JNB and 21 CFR 862.1555, within the Clinical Chemistry review panel as a Class II device.