Clearance Summary
BIOFIX received FDA 510(k) clearance under submission number K843428, sponsored by Accra Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1984-09-27.
- Submission: K843428
- Applicant / Sponsor: Accra Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1984-09-27
Classification & Regulation
This clearance is catalogued under FDA product code LDZ and 21 CFR 864.4010, within the Pathology review panel as a Class I device.