Clearance Summary
OC-Auto SENSOR io iFOB Test received FDA 510(k) clearance under submission number K191147, sponsored by Eiken Chemical 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 2020-01-02.
- Submission: K191147
- Applicant / Sponsor: Eiken Chemical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2020-01-02
Classification & Regulation
This clearance is catalogued under FDA product code OOX and 21 CFR 864.6550, within the Hematology review panel as a Class II device.