Clearance Summary
MONOHAEM (FECAL OCCULT BLOOD TEST) received FDA 510(k) clearance under submission number K901064, sponsored by Silenus Laboratories Proprietary , 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 1990-11-05.
- Submission: K901064
- Applicant / Sponsor: Silenus Laboratories Proprietary , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1990-11-05
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.