Clearance Summary
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST received FDA 510(k) clearance under submission number K063693, sponsored by New Bay Bioresearch Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-05-11.
- Submission: K063693
- Applicant / Sponsor: New Bay Bioresearch Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2007-05-11
Classification & Regulation
This clearance is catalogued under FDA product code KHE and 21 CFR 864.6550, within the Hematology review panel as a Class II device.