Clearance Summary
HEMOCCULT-C received FDA 510(k) clearance under submission number K832311, sponsored by Menley & James Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-02-27.
- Submission: K832311
- Applicant / Sponsor: Menley & James Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1984-02-27
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.