Clearance Summary
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT received FDA 510(k) clearance under submission number K990654, 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 1999-06-21.
- Submission: K990654
- Applicant / Sponsor: Quantase , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1310
- Decision date: 1999-06-21
Classification & Regulation
This clearance is catalogued under FDA product code JIA and 21 CFR 862.1310, within the Clinical Chemistry review panel as a Class I device.