Clearance Summary
QUICK CULT SLIDE TEST FECAL OCCULT BLOOD received FDA 510(k) clearance under submission number K761232, sponsored by Laboratory Diagnostics Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1976-12-21.
- Submission: K761232
- Applicant / Sponsor: Laboratory Diagnostics Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1976-12-21
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.