Clearance Summary
DS30 HCY BLOOD COLLECTION TUBES received FDA 510(k) clearance under submission number K012152, 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 2001-09-18.
- Submission: K012152
- Applicant / Sponsor: Drew Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2001-09-18
Classification & Regulation
This clearance is catalogued under FDA product code GIM and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.