Clearance Summary
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T received FDA 510(k) clearance under submission number K073431, sponsored by Tianjin New Bay Bioresearch Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2008-01-14.
- Submission: K073431
- Applicant / Sponsor: Tianjin New Bay Bioresearch Co., Ltd.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2008-01-14
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.