Clearance Summary
DS30 HCY HOMOCYSTEINE ASSAY KIT received FDA 510(k) clearance under submission number K982003, sponsored by Drew Scientific , 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 1999-02-11.
- Submission: K982003
- Applicant / Sponsor: Drew Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1377
- Decision date: 1999-02-11
Classification & Regulation
This clearance is catalogued under FDA product code LPS and 21 CFR 862.1377, within the Clinical Chemistry review panel as a Class II device.