Clearance Summary
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT received FDA 510(k) clearance under submission number K043378, sponsored by Drew Scientific , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-12-29.
- Submission: K043378
- Applicant / Sponsor: Drew Scientific , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2004-12-29
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.