Clearance Summary
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT received FDA 510(k) clearance under submission number K000754, 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 2000-06-19.
- Submission: K000754
- Applicant / Sponsor: Quantase , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1555
- Decision date: 2000-06-19
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.